Quality Assurance Specialist Resume Samples

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D Steuber

Delpha

Steuber

2594 Janis Land

New York

+1 (555) 693 8292

2594 Janis Land

New York

Phone

p +1 (555) 693 8292

Experience Experience

Los Angeles, CA

Quality Assurance Specialist

Los Angeles, CA

Jacobson-Mosciski

Los Angeles, CA

Quality Assurance Specialist

Review Contracted Service Provider (CSP) records and procedures as provided. Perform QA review and provide feedback to CSPs
Perform audits of Velocity Resident Billing output, provide associated reporting. and make recommendations to improve quality
Perform audits of Velocity Resident Billing Implementation configurations, provide associated reporting. and make recommendations to improve quality
Works with the QA Manager to provide support and guidance for current Quality Staff in the network
Assist the QA Manager in maintaining risk-driven Quality Management Plan (QMP) for end-to-end audits and reviews
Interacts with Coaches/Operations Managers and Senior Team Manager to remedy system or script problems that may affect Trusted Professionals performance
Coordinate work assignments, managing work schedules and reviewing work-in-progress with the other QA staff

present

Detroit, MI

Quality Assurance Specialist

Detroit, MI

Grimes Group

present

Detroit, MI

Quality Assurance Specialist

present

Assist in developing and executing a quality assurance program to include agent performance standards and workflow for the Contact Center
Work closely with the Nuclear QA Manager to provide guidance in applying the QA Program with QA/QC, field engineers, and project managers
Provide suggestions to ensure improvement in adherence to quality standards and improve overall team performance
Assists in developing quality systems & make recommendations for improvements to existing Quality systems
Communicate QA feedback issues to operations Team Leaders & Manager. Coordinate closely with team leaders and/ or managers on quality performance management
Performs audits of the effectiveness of development processes and work products and recommends improvements as necessary
Work with the QA Manager to identify performance improvement opportunities by analyzing quality data and coaching documentation

Education Education

Bachelor’s Degree in Science

Temple University

Bachelor’s Degree in Science

Skills Skills

An accountable team player who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures
Quality certification (from American Society for Quality or equivalent), is highly desirable
An accountable team player who is detail and quality oriented with an understanding of quality assurance principles, systems, and procedures
Registered Quality Assurance Professional – Good Clinical Practices (RQAP-GCP) from the Society of Quality Assurance
Strong organizational skills, ability to pay attention to detail, good verbal and written skills
Knowledge of functionality, compatibility, usability, reliability, exploratory, and load/stress testing practices
Ability to show exceptional attention to detail, and be able to interact well with others
Great attention to detail, process-orientation and the ability to stay focused while performing the review
The ability to demonstrate a strong understanding of good customer service principles
Able to solve problems and make informed decisions, using knowledge, logic and good judgment

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Quality Assurance Specialist Resume Examples & Samples

Some previous experience or education needed to satisfactorily perform the job
Ability to work under strict time constraints and change priorities
Basic computer knowledge; Microsoft Office. Ability to learn new applications
Basic knowledge of textiles and apparel manufacturing
Familiarity with the Federal Trade Commission (FTC) and Consumer Product Safety Commission (CPSC) resources

Quality Assurance Specialist Resume Examples & Samples

Familiarity with key anti-money laundering and anti-terrorist financing legislative requirements and regulatory expectations
Familiarity with money laundering and terrorist financing risk issues, including familiarity with the AML/ATF risk associated with various products, customers and jurisdictions and their application to the business of the Enterprise
Ability to assist in identifying and analyzing patterns and connections among AML issues across Operating groups
Understanding of the Enterprise’s businesses
Understanding of the Enterprise’s approach to risk management
Ability to assist in recommending improvements to control activities and the operating environment based on information derived through risk assessments, monitoring activities and regulatory requirements pertaining to sanctions measures
Ability to assist in promoting consistency in AML/ATF approach through the Enterprise
Organizational Understanding – Knowledge of US AML processes and operations, including LOBs and AML Operations
Risk Management – Ability to identify risks associated with money laundering and terrorist financing activity as they apply to the business of the Enterprise
Analytical Thinking – Ability to analyze, on an in-depth basis, results of monitoring and oversight activities conducted by AML compliance staff
Regulatory Knowledge – Knowledge of regulatory requirement s/expectations pertaining to risk assessments and related matters, and apply them to the US businesses
Controls/Monitoring – Knowledge of Audit, internal controls and/or similar oversight procedures would be an asset
Communication – Ability to clearly communicate at all levels of the Enterprise
Problem Solving – Ability to identify potential solutions to address risks; At BMO Harris Bank, we have been helping our customers and communities for over 130 years. Working with us means being part of a team of talented, passionate individuals with a shared focus on working together to deliver great customer experiences. We stand behind your success with the support you need to turn your potential into performance

Quality Assurance Specialist Resume Examples & Samples

Develop QA recognition programs
Establish QA monitoring goals for each project and communicate goals to QAS
Track progress toward goals throughout the course of each month
Provide meaningful monthly reviews of productivity and performance based on projected goals
Assist and support the national QA effort, striving for national calibration and consistency
Oversee the Quality Assurance training and certification of all local evaluators and Supervisors
Partner with Center Leadership Team to stay informed of changes in policies, procedures and
Support and assist Operations
Strong communication and organization skills, detail-oriented and self-motivated
Demonstrate ability to document and communicate employee performance evaluations in a positive and effective manner. Able to handle escalated employee concerns and discipline scenarios
Knowledge of Microsoft Word, Excel, PowerPoint and Outlook
Ability to work in a fast-paced environment with frequent deadlines

Quality Assurance Specialist Resume Examples & Samples

Accountable for continuous quality improvement of the client experience, supporting the Advice Centres, Field Sales and back office operations
Proactively detect, report and monitor for continuous quality improvement of the delivery of sales and service; identifying trends, observations and opportunities against established service partner agreements
Applies product, procedural and technical knowledge supporting and enabling a high performance culture; understands the end-to-end process of sales and service cycle times and client experience impact
Participates in team and business partner calibration sessions, sharing identified trends, observations and opportunities for improvement to realize tangible benefits to the business and the organization
Tracking and monitoring personal and team productivity and performance, adhering to established targets and service level agreements

Quality Assurance Specialist Resume Examples & Samples

Product & Process
Risk & Control
Business Performance Management
2 to 3 years of related experience
Good knowledge and understanding of the business unit’s key products and services, processes and controls
Good understanding of the business unit’s risk and regulatory requirements
Good knowledge of departmental systems and applications
Good investigation skills
Good prioritization skills
Good customer service and relationship management skills
Good written and oral communication skills a

Quality Assurance Specialist Resume Examples & Samples

Works closely with team members to identify opportunities for improving efficiencies related to improving operational compliance
Assists in handling escalated issues in an urgent matter to mitigate potential risk of financial loss to the client and/or firm
Gathers information on error activity and reviews results with supervisor to determine root cause; implements action items based on management recommendations for avoiding future errors
Assists with the monitoring of various audit controls and functions to ensure appropriate procedures are being followed
Works with supervisor to develop reporting methods that identify progress against identified errors
Assists supervisor with identifying training needs that will improve inefficiencies
Assists supervisor with the development of training materials to address areas identified
Conducts necessary group and individual training related to improving operational compliance
Maintains records of training activities and participants to generate accurate reports
At the direction of a supervisor, works on special projects focused on increasing the effectiveness of audit functionality to ensure compliance with appropriate regulations
Assist with compiling and maintenance of reports generated involving auditing/compliance functions
Operations and systems of assigned functional area
Basic investment concepts, practices and procedures used in the securities industry, principles of banking and finance and securities industry operations and/or financial markets and products, as required by assigned functional area
Identifying and resolving systemic and operational issues
Analyzing operational processes and identifying opportunities for improvement
Operating standard office equipment and using required software applications
Provide cross-training and coaching related to those areas assigned to
Learn and apply complex financial regulations to daily functions
Partner with other functional areas to accomplish objectives
Attend to detail while maintaining a big picture orientation
Read, comprehend and apply business-related information
Incite enthusiasm and influence, motivate and persuade others to achieve desired outcomes without organizational authority
Interpret and apply policies and identify and recommend changes as appropriate
Organize, manage and track multiple detailed tasks and assignments with frequently changing priorities in a fast-paced work environment
Communicate effectively, both orally and in writing
Work independently as well as collaboratively within a team environment
Serve as a role model and lead others in providing a high level of customer service
Associate's Degree and a minimum of two (2) years experience in operations

Quality Assurance Specialist Resume Examples & Samples

Review work papers to ensure compliance with Global Compliance Testing Procedures requirements
Perform QA reviews on work papers and reports before issuance
Review reports and ensure work papers and evidential matter supports the report issues, observations, ratings and conclusions
Assist with the Annual Compliance Plan and reporting on the team’s progress to plan
Maintain the inventory of test scripts and test procedures, update as needed for new regulations
Monitor the business units’ progress of issues and remediation plans and report remediation progress
Analyze and review monitoring findings, conclusions and corrective actions to ensure Firm quality review standards are met
Support future process enhancements for the Bank Group Compliance testing team
Assist with the preparation of PowerPoint presentations as needed
Assist with the compilation of monthly metrics for management and reporting purposes
Participate in special projects and regulatory requests as needed
Maintain awareness of current industry rules, regulations and best practices to ensure that the QA program meets regulatory standards
Assist in updating policies, procedures and departmental guides, as needed
Assist in assessing the team’s training needs and requirements
Have 5-10 years of professional experience within the banking, financial services or mortgage industry in a compliance, internal/external audit or QA capacity or experience within a financial services regulatory agency relevant to the applicable jurisdiction
MBA, JD, CPA or CRCM desired
Have some knowledge of QA best practices and QA techniques
Have some knowledge of Banking Regulations and/or Mortgage regulations
Possess an understanding of the banking regulatory environment including familiarity with various federal functional regulators relevant to the applicable jurisdiction, such as the OCC, CFPB, FDIC, FRB, CFTC and/or NFA
Possess an understanding of financial markets and banking
Maintain awareness of current laws, rules and regulations related to Banking and Mortgage
Possess strong leadership qualities with the ability to manage small teams, while assessing and developing individual and team skills and providing timely constructive feedback
Have the ability to use various PC, MS Office and internet applications and tools to support testing processes
Be self-motivated and must have the ability to work independently

Quality Assurance Specialist Resume Examples & Samples

Evaluates incoming calls & emails to ensure “magical” service is provided on all customer contacts
Ensures QA and management teams are calibrated by participating in and reporting on monthly call/email calibration sessions
Provides actionable data to various internal support groups as needed
Ensures knowledge of business practices by taking 4 hours of calls or escalations each month and by attending all applicable call center trainings
Identifies potential enhancements or content clarifications to call/email models and monitoring forms
Strong working knowledge of zulily processes or 1 year of comparable call center/customer service experience
Exceptional listening and organizational skills
Dedicated to providing exceptional customer service to internal/external customers
Ability to implement new processes and procedures
Exceptionally rigorous work ethic, adaptable to ever-changing hours and demands

Quality Assurance Specialist Resume Examples & Samples

Receive and log product complaints from a variety of sources
Provide support on failure evaluation of returned products
Follow up on outstanding evaluations to ensure timeliness and regulatory compliance
Support Adverse Event Reporting Regulatory Requirements
Under limited supervision draft responses to specific product complaint and vigilance report queries from Competent Authorities
Monitor customer complaints and provide immediate feedback to concerned personnel when critical issue is detected
Ensure effective CAPA is taken to help prevent reoccurrenceQARA PMS Specialist
Supporting the Field Action process including
Ensuring that any Recall strategy provided by a Legal Manufacturer is complied with Ensuring appropriate recall activities are documented, approved and communicated to relevant parties
Consignee List coordination and circulation
Preparation and obtaining approval of Field Safety Notices, Field Safety Corrective Action Forms in conjunction with the Coordinating Competent Authorities along with Management
Collaboration with appropriate personnel to translate the field correction communication and issue of same to Regulatory Authorities (inc. other CAs, NBs) with their regions along with consignees
Coordination of the issue of the Field Notice and reconciliation of Acknowledgement status from consignees
Reconciliation of product returns versus stated returns on Acknowledgement form prior to final disposition of same
Coordination of the final disposition of any returned affected product
Requesting closure of field corrective actions from affected Regulatory Authorities Compilation and Archiving of all records' associated with the Field Action activity
Provide support for the risk management process and provision of complaint data to risk management groups
Support other activities in the post-market surveillance system as it develops

Quality Assurance Specialist Resume Examples & Samples

Must have at least 2 to 4 years of retail management experience. Prior retail store leadership experience preferred
College degree or relevant technical or vocational training preferred
Must be skilled in leadership, coaching, and training, sales generation, strategic planning, authentic customer service, communication, conflict resolution, business acumen, time management, and POS and other retail software proficiency
Must be able to provide feedback, develop others, embrace and lead change, and make decisions under ambiguity
Must have excellent interpersonal skills and be able act with integrity and professionalism to ensure that all business is conducted without bias or prejudice
Must be able to maneuver around sales floor and stock rooms, work with cleaning chemicals, and lift and carry up to 50 lbs
Must be available to work a flexible schedule to meet the needs of the business, including 2 closing shifts per week and 2 full weekends per month

Quality Assurance Specialist Resume Examples & Samples

Understanding of the application architecture
Understanding of the purpose of the application and how it fits into the global business
Create test plans and design test cases
Run functional and non-functional tests on the application
Create automated tests (QTP, Selenium, Python) & test automation tools (C#)

Quality Assurance Specialist Resume Examples & Samples

3 -5 years of previous experience in Quality, Packaging or direct to consumer industry
Experience working and communicating with international and domestic vendor base
Ability to multi task, follow process and work independently
Knowledge of product quality and craftsmanship, construction and high-end materials
Knowledge of Distribution and Supply Chain
Custom compliance: NIST, LACEY ACT, HTS and ISF is a plus
Microsoft Office, Pkms, Ecometry

Quality Assurance Specialist Resume Examples & Samples

Deep understanding of munitions management and munitions systems
Extensive knowledge of the ammunition management process, top down and bottom up, for training, operational, test, sustainment and combat ammunition accounts
Knowledge of TAMIS, SAAS-MOD, GCSS-A, GCSS-MC, OIS-MC Tactical, FMSWeb, AOS or WebAmmo
Specialized technical and/or functional munitions experience
Specialized experience in munitions supply procedures
US Army or Marine Corps munitions regulatory knowledge
Experience with STRAC or Marine Corps munitions requirements generation processes
Understanding and current knowledge of the Army force structure
Knowledge of DA PAM 350-38, AR 5-13, AR 220-1
Ability to interact professionally with managers, customers and team members
Experience using Team Foundation Server (TFS)
Military experience desired
Minimum Experience: At least 6 years Quality Assurance experience
BS in Computer Science or other IT field desired
Munitions experience required
Ability to get a Secret Clearance required

Quality Assurance Specialist Resume Examples & Samples

The Quality Assurance Specialist will perform work that requires a practical knowledge of the nature and operations of submarine repairs / refurbishments, and the materials, facilities and capabilities of the various repair activities available to perform these repairs and alterations
The Quality Assurance Specialist must understand the unique requirements of nuclear powered vessels, SOC, FBW and SUBSAFE, and the QA and objective quality evidence required of such repairs
The Quality Assurance Specialist will advise and assist the Material/Quality Assurance Officer on matters pertaining to Quality Assurance, SOC, FBW and SUBSAFE programs including
The Quality Assurance Specialist performs annual SUBSAFE/SOC/FBW awareness training for staff members that routinely review SUBSAFE/SOC/FBW objective quality evidence, and makes determinations on
10+ years experience in submarine repair including significant experience in submarine Quality Assurance (QA) and Scope of Certification (SOC) requirements
10+ years working on SUBSAFE programs on submarines
Demonstrated ability to interface with senior personnel (Military 06 and GS 14/15)
Experienced as a 2nd level Supervisor on a submarine or in a Submarine repair activity

Quality Assurance Specialist Resume Examples & Samples

Review and approve label artwork and content and ensure adherence to all applicable rules and regulations
Conduct research and advise on international import requirements and timing
Collaborate with internal and external customers by providing regulatory support to CPG Brand Management, Research & Development, Quality Assurance, suppliers, and importers/distributors
Work with international regulatory partners to secure timely regulatory approval for products being exported globally
Manage technical product documents, including retrieval, review, modification and storage
Resolve issues related to product approval in international markets by obtaining technical product information, supplier declarations/certifications, ingredient information, test results, etc
Experience with reviewing and approving food and beverage labels: 1-3 years
Experience in interpretation and application of food and beverage regulations in the US, Canada, Latin America, Europe, and Asia: 1-3 years
Experience consulting stakeholders on how to comply with food and beverage regulations: 1-3 years
Experience collecting, reviewing, and managing technical product information and regulatory documents: 1-3 years
Current knowledge of FDA guidelines and regulations
Bachelor’s degree in Food Science, Nutrition, International Business, International Studies, or a related field
Ability to handle large volumes of technical reports and information in an organized manner
Familiarity with formulation of food products and food processing
Ability to work independently without close supervision on a daily basis, over time
Ability to communicate effectively and influence internal and external customers
Ability to multitask, maintain attention to detail and remain calm under pressure

Quality Assurance Specialist Resume Examples & Samples

Batch documentation review and approval prior to product release. Liaising with contract manufacturing organisations that manufacture and package Shire’s products to ensure that batch documentation and manufacturing and packaging processes comply with GMP standards, products’ marketing authorisations and Shire’s quality requirements
Using Shire’s Enterprise Resource Planning (ERP) applications to manage status of material according to material disposition
Escalating quality incidents to appropriate level of quality management
Managing communication between the quality unit responsible for batch release and other stakeholders in order to align on and meet batch review/release expectations
Reviewing and approving batch records, specifications, deviations, change controls, and SOPs
Reviewing investigations
Performing audits
Facilitating product complaints investigations
Assisting with regulatory agency inspections
Supporting Product Quality Reviews
Time management and prioritization competencies
Critical thinking/evaluation of process problems
Familiarity with interacting with and interrogating ERP applications
Ability to trend and evaluate data
Proactively addressing compliance issues and escalate appropriately
Ability and experience to develop gap analysis and action plans

Quality Assurance Specialist Resume Examples & Samples

Developing and documenting test plans, test cases, and/or test scripts based on requirements and specifications
Identifying appropriate data needed for software testing
Working closely with development staff to report issues and determine appropriate resolutions
Documenting test results in a consistent format, adhering to organization standards
Strong analytical and problem solving skills with 5+ years proven experience in quality assurance and testing function
Ability to take direction and juggle multiple priorities with minimal supervision
Proven flexibility and adaptability in effectively driving results in an environment of changing priorities
Strong interpersonal skills, with ability to build and cultivate strong partnerships
Proven ability to work independently on multiple tasks with commitment and willingness to see issues through to resolution
Ability to find innovative solutions; ability to think critically and creatively
Ability to understand complete project life cycle methodology
Knowledge of, or experience with, automated testing tools and financial concepts (equity markets, trading concepts, financial instruments, derivatives, hedge funds) a plus

Quality Assurance Specialist Resume Examples & Samples

Bachelor’s degree in scientific or technical discipline
Proficiency with computer systems, including Microsoft Office Suite and Trackwise
Outstanding organizational and communication skills

Quality Assurance Specialist Resume Examples & Samples

Spot-check installations via telephone and physical customer visits to assess the quality of work being performed by local Satellite TV Installer / Technicians
Responsible for identifying and resolving potential work quality issues to resolve customer satisfaction
Schedule customer appointments for Quality Assurance Inspections
Ensures adherence to quality assurance guidelines to ensure 100% customer/client satisfaction
Assist efforts to educate technicians on the latest products and applications to achieve high quality service
Responsible for monitoring and reporting to the management team any safety or performance issues regarding all installations #CB2

Quality Assurance Specialist Resume Examples & Samples

60%: Records review
40%: Quality System Management and Improvement
A minimum of a B.S. degree in science or engineering with at least 3 year’s relevant experience executing, developing, and/or administrative GMP quality programs in cGMP biotech and/or pharmaceutical environments
Proficiency with Microsoft applications Word, Excel, Project and PowerPoint; ability to learn additional software applications, as the need arises
Strong written and oral communication skills required
Teamwork skills are essential
Ability to multi-task in a dynamic environment with changing priorities
Delivering Excellence
Self-Knowledge

Quality Assurance Specialist Resume Examples & Samples

Develop, maintain monitoring and audit productivity of quality initiatives and their status for assigned Care Supervisor teams- NYC Regional Care sites
Track and investigate areas of improvement using various quality databases -QMS monitoring tool, TWC Sponsored Corp My Quality and Nexidia Speech Analytics tool; communicate findings with leaders and provide ongoing follow up for performance results tracking
Analyze and evaluate customer trending using the Nexidia Speech Analytics tool; collaborate with department leaders to maximize the benefits of the Speech Analytics tool
Track and report any system issues and timely notification to regional users
Maintain absolute confidentiality of all records
Perform other related business duties as assigned by the Supervisor and management as required

Quality Assurance Specialist Resume Examples & Samples

Loan IQ knowledge is STRONGLY preferred
Experience in Investment Banking, Commercial Banking, Business Banking, and/or Private Banking is a plus
Intermediate to advanced use of Microsoft Word, Excel, Access is a plus

Quality Assurance Specialist Resume Examples & Samples

Adheres to rebate processing quality standards by studying program manuals and training presentations; ensures applications are processed accordingly to program guidelines
Verifies results & accuracy of information by documenting and tracking processing errors during application review
Provides feedback to team & supervision by evaluating applications & ensuring detailed notes are recoded within the monitoring form; monitoring to ensure program updates are applied by the processing team, ensure applications are processed as outlined for that specific program
Assists with quality initiatives by providing feedback regarding common trending, errors, etc in an effort to partner with our internal training department to provide continuation training material
Maintains professional and technical knowledge by attending any continuation trainings offered for programs specific to those the Quality Assurance Specialist reviews
Basic computer skills including proficiency with MS Word, Excel and other programs within the MS Office Suite
Previous customer service experience strongly preferred
Previous business processing or back office experience strongly preferred
Previous experience as a call center agent is ideal
Computer skills to include data entry, database navigation and database manipulation preferred
Strong communication skills, both written and oral, required
Ability to display high energy level, positive attitude and enthusiasm for the program while offering customer service over the phone
Strong analytical, problem-solving and decision making capabilities required
Team player with the ability to work in a fast-paced environment is a must
Superior interpersonal skills including courtesy, professionalism, and a cooperative attitude required
Ability to be flexible to handle multiple priorities and to work limited overtime as necessary required

Quality Assurance Specialist Resume Examples & Samples

Proficiency with Microsoft applications Outlook, Word, Excel, Project, and PowerPoint
Prior experience with TrackWise
Ability to learn additional software applications as the need arises

Quality Assurance Specialist Resume Examples & Samples

BS Degree in Science or Engineering
3-5 years of relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments
Experience with TrackWise, SAP and LIMS
Previous experience in support of manufacturing operations
Knowledge of regulatory requirements and guidelines for US and Europe

Quality Assurance Specialist Resume Examples & Samples

3+ years of relevant experience executing, developing, and/or administrating GMP quality programs in cGMP Biotech and/or Pharmaceutical environments
Bachelor's Degree in Science or Engineering
Working knowledge of TrackWise, SAP and LIMS
Proficiency with Microsoft Office/Suite proficient (Outlook, Word, Excel, Project, and PowerPoint)
Experience supporting manufacturing operations

Quality Assurance Specialist Resume Examples & Samples

Assists technical manager in auditing, visiting and qualifying co-manufacturers and vendors. Oversees monthly plant audits and twice-yearly mock recalls
Coordinates movement of samples through quality evaluation process and tracks lab responsibilities. Performs testing and analysis as necessary
Ensures department needs are achieved by hiring, training and leading quality assurance technicians
Maintains facility certifications and regulatory licenses. Provides documentation to auditors, applies for renewals, and participates in certification audits
Oversees holds and releases of raw materials and finished product. Ensures that regular reports of product status, including raw material, blend and finished product, holds and corrective actions, are provided to Operations
Oversees maintenance of Quality Assurance lab according to cleanliness standards. Ensures equipment is calibrated and in working order
Works with co-packers and vendors to communicate and ensure compliance to Evolution Fresh technical requirements as outlined in technical manuals. Provides Operations team with reports on vendor performance
Laboratory (2 years)
Auditing raw materials and finished goods (1 year)
Good Manufacturing Practices (GMP) application (1 year)
Hazard Assessment and Critical Control Points (HACCP) (1 year)
Ability to lead and train others
Ability to perform data entry
Basic skills in Microsoft Word, Excel and Access
Analytical, systems-thinking skills

Quality Assurance Specialist Resume Examples & Samples

Perform material/supplier investigations supporting raw material quality issues
Perform change control management of supplier initiated changes
May own specifications, non-conformance & CAPA records and change records
Negotiate quality agreements with suppliers
Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.)
May own site quality system(s) and standard operating procedures
May represent ACO on global network teams and support of new initiatives
Metrics compilation and reporting
Provide SAP expertise
Significant experience gained within the pharmaceutical or biotechnology industry
Experience working with raw material suppliers
Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable
Operational Excellence experience desirable
Experience utilizing Lean principles and a risk-based approach desirable

Quality Assurance Specialist Resume Examples & Samples

Responsible for conducting planned and unplanned review of Account Solutions work to ensure compliance with established quality standards and guidelines, including call monitoring
Responsible for reviewing collection administrative and bankruptcy processes to ensure compliance with applicable regulations and internal standards
Publish and submit his/her audit findings to the VP of Account Solutions along with appropriate recommendation to improve collection performance
Understanding of the department processes and guidelines
Defining and establishing the overall quality strategy and to determine, investigate, and resolve data quality issues
Establishing an on-going process to maintain quality data and defining quality audit processes
Identifying and leveraging opportunities to improve the quality management processes, systems, and standards
Participate in planning and developing procedures to meet regulatory requirements and organizational objectives
Assist in the development and implementation of quality control plan
Conduct regular review of collection processes and make recommendation to enhance team efficiency and effectiveness
Maintain awareness of state and federal regulations affecting collection activities and make appropriate recommendation to ensure compliance
2-year college degree preferred
3-year experience in quality control
4+ year experience in customer service in a financial institution
Knowledge of US Bankruptcy Process
Knowledge of Collection Process
Knowledge of collection process for non-BK charge-off recovery members
In-depth knowledge of the Fair Debt Collection Practices Act, repossession and bankruptcy law
Demonstrated leadership and strategic thinking ability
Very strong organizational skills with the ability to meet numerous deadlines in a fast-paced environment
Goal Oriented Team player
Strong knowledge of Microsoft Word and Excel
Strong decision-making skills
Ability to communicate adverse information in a diplomatic and professional manner

Quality Assurance Specialist Resume Examples & Samples

Participates in product requirements, design and user documentation review
Independently develops test strategy, procedures and cases based on requirements
Understands the use cases, product design and architecture, design high quality test cases
Designs, develops and executes test plans
Test automation and tool development
Effectively executes test cases
Troubleshoots problems with application, utility, Operation System and hardware setup
Effectively communications
Assure and Assesses product quality
Bachelor's degree in computer science or electronic engineering
3+ years hands-on experience in software test
Broad knowledge in Unix/Linux Administration, Network Administration, Server Administration or the verification of system software
At least skilled in one of programming languages Java, Perl/Python/Shell
Good understanding software process and test process
Familiar with product requirement/design review and use case development
Excellent communication, teamwork, and interpersonal skills are a must
Self-disciplined, working proactively and fast learning are a must
Knowledge of mainstream virtualization technologies (e.g., KVM, VMware, Xen) is a plus
Knowledge of cloud computing technology (e.g., SoftLayer, EC2) is a plus
Knowledge of IBM Platform LSF/Symphony technology is a plus

Quality Assurance Specialist Resume Examples & Samples

Own verification and testing for full system adherence to policies and standards
Use of full and complete knowledge of the systems and detailed record keeping
Prioritize tasks, personnel, and resources to determine the accuracy and quality of systems
Generate data to drive optimization and future improvements to standards and policies
Use security-team company tools to track project metrics, inter-department needs, and risk factor notifications
Manage security systems logistics, documentation, and reports
Communicate information effectively to supporting teams, stakeholders and management through entirety of all project objectives and determine opportunities for improvement
Drive the delivery of accurate data for a complete and accurate final product
Manage timelines and meet deadlines through coordination and preparedness
Contribute to security systems programming projects, testing, and documentation to best meet security needs of sites and deadlines
Stay abreast of the latest security technologies and how they fit into the standards

Quality Assurance Specialist Resume Examples & Samples

75%: Supporting on-the-floor Manufacturing Operations
Perform routine manufacturing area inspections to ensure compliance with company procedures/policies, cGMP principles, and regulatory requirements (US and international)
Review and approve new documents requests and/or document revisions
15%: Providing general off-the-floor QA consultation to manufacturing and support departments
10%: Supporting miscellaneous QA tasks
Self-motivated and driven to independently accomplish department goals and objectives

Quality Assurance Specialist Resume Examples & Samples

Plan, design, develop, execute and report regression, functional and non-functional tests for new system releases and automate them as much as possible
Track software faults and bug reports in HP Quality Center
Review requirement specifications and technical documentation for accuracy
Work closely with the development team to investigate and solve major software incidents (Agile)
Builds automated test for front-end facing applications using Unified Functional Testing
Creates own test environments using virtual machines to ensure that all testing is done as close to production specifications as possible
Creates detailed sprint reports at the end of each sprint, as well as roll-out reports before releases which were handed to the Scrum Team and Product Owner
Ensured that the tests that were performed were reflected in real time with HP Quality Center used for managing test plans and test cases
Create scenario for Performance testing using HP Load Runner
Scanning web applications with tools specialized sites in order to detect vulnerabilities of code. (HP Webinpsect)

Quality Assurance Specialist Resume Examples & Samples

High school education or equivalent. Four year college or equivalent is preferred
1-3 years previous call center experience, TCF experience is preferred. Quality Assurance experience is preferred
Candidates must be able to demonstrate proficiency in the following skills as well

Quality Assurance Specialist Resume Examples & Samples

3-7 years of experience
Previous batch record review experience
Pharmaceutical / Biotechnology experience
Ability to multitask
Experience in Trackwise,SAP program, and LIMS

Quality Assurance Specialist Resume Examples & Samples

Manage the activities of a defined team of QA personal to ensure full compliance of the QMS, including documentation
Manage and improve the incoming inspection process
Maintain equipment control schedule and records
Work with the operations team to ensure the release of compliant product
Support training of staff on quality standards and procedures
Degree in Engineering, Scientific or Quality is required
A minimum of 2 years' experience in a QA role in a med device/pharma production facility
Strong documentation and process experience
Strong GMP experience
Strong ability and willingness to hit the ground running and keen interest to learn
Proven ability to work in a high pressure environment

Quality Assurance Specialist Resume Examples & Samples

Experience with simple SQL queries and data tables
Knowledge of automated testing tools and their usage
Ability to translate from business requirements to technical testing solutions
Experience with full cycle testing including functional testing, system testing, integration testing, performance and stress testing
Ability to multi-task while maintaining careful attention to detail
Ability to work with a sense of urgency to meet deadlines and address competing priorities
Proficient skills with Microsoft Office software including Word, Excel, PowerPoint and Outlook
Effective problem solving and organizational skills
Minimum of 3-5 years of experience in technology testing required
Experience with investment software testing preferred
Experience working within Financial Services industry preferred
Equivalent education and experience will be considered

Quality Assurance Specialist Resume Examples & Samples

Design, document and execute test procedures
Conduct test entry reviews and record and document test results
Manage all aspects of User Acceptance Testing
Investigate, recommend, implement and manage testing tools
Coordinate with the Projects and Application Development teams to drive product quality
Participate in business requirements documentation reviews to extract test scenarios
Work closely with Application Development Group to promote software quality standards
Work closely with the Projects Group to replicate customer issues and application use cases

Quality Assurance Specialist Resume Examples & Samples

Manage product categories to ensure quality standards meet or exceed our brand objective
Test/Use/Assemble new products/furniture to ensure the goods meets our brand quality standards for functionality, fit, finish, and real life performance
Maintain close vendor relationships to ensure testing is performed per legal regulations
Daily updating and documentation of a product’s progress and raise awareness when risk of the product life cycle and ship date may be compromised
Constant review and analysis to identify high return rate items and establish a corrective action plan to resolve
Create/Develop/Negotiate packaging specifications with vendors to ensure packing mitigates damages and proudly represents our brand image
Initiate third party factory inspections to ensure production and pre-shipped goods meets our quality standards
Address, validate and close negative feedback/reviews identified through BazaarVoice channel
Train vendors on our vendor compliance/shipping practices to ensure seamless receipt into our distribution centers
Review and approve all vendor assembly instructions and care/maintenance documents and ensure posting for online web review
Report results of items tested to Merchant team and provide factual feedback at product review
Collaborate with Merchants on timelines and resolutions to correct identified failures
Attend product review and vendor product presentation meetings providing feedback on tested products performance and or necessary corrective actions on poor performing product

Quality Assurance Specialist Resume Examples & Samples

Perform all activities in compliance with site safety standards and SOPs
Write, review and approve Standard Operating Procedures in accordance with company Policies
Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

Quality Assurance Specialist Resume Examples & Samples

Bachelor's Degree in Chemistry, Biology or a related discipline
5 years of Quality Assurance experience supporting the manufacture of drugs, biologics, or devices
Experience in applying phase appropriate cGMPs to Clinical Product Life Cycle
Understanding of quality systems, cGMPS and Regulatory Agency guidance as applicable to drugs or biologics
Strong Quality Assurance knowledge
Polished and professional demeanor $
Previous experience in QC

Quality Assurance Specialist Resume Examples & Samples

Responsabilities
Performs evaluations based on guidelines provided by IBM and the supported client
Delivers evaluation feedback and coaching to agents on a weekly or daily basis
Creates and develops continuous improvement ideas for operations
Creates and communicates Quality related reports
Leads internal and external calibrations per business needs
Maintains updated with all company’s procedures and product knowledge
Takes on additional responsibilities as assigned
Participates in the creation of all training material related to QA position
Delivers coaching and feedback to agents within 24hrs from evaluation
Process oriented, capable of designing, implementing and improve processes
Developed computer skills – Word, Lotus Notes, Excel, Explorer, etc)
Good interpersonal skills – able to work as part of a team
Organization skills, well structured
One year of experience in related positions

Quality Assurance Specialist Resume Examples & Samples

Review, evaluate and score Delinquency Management and Loss Mitigation customer contact calls to determine if calls are handled in compliance with FDCPA, CFPB and internal operating standards
Provide assistance for training and clarification for compliance updates, changes and areas of improvement
Provide feedback and reporting on compliance and quality
Review focus sets of calls, with analytics input, to assess against specific business criteria
Conceptual Thinking:The ability to find effective solutions taking a holistic, abstract, or theoretical perspective
Initiative:Identifying what needs to be done and doing it before being asked or before the situation requires it
Results Orientation: The ability to focus on the desired results of one’s own or one’s team work; setting challenging goals, focusing effort on the goals, and meeting or exceeding them
Thoroughness:Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations

Quality Assurance Specialist Resume Examples & Samples

AA Degree in related field or equivalent work experience
Knowledge of Patelco Credit Union’s products and services, policies and procedures, and regulatory requirements (preferred)
Excellent written and oral communication skills; strong organizational, problem-solving, and analytical skills
Proficient in MS applications, including Word, Excel and Outlook
Ability to work with minimal supervision and effectively prioritize workload
Must be able to travel to Patelco Headquarters and/or MCC Merced
Demonstrated experience and passion of delivering superior Member Service

Quality Assurance Specialist Resume Examples & Samples

Conceptual Thinking: The ability to find effective solutions taking a holistic, abstract, or theoretical perspective
Initiative: Identifying what needs to be done and doing it before being asked or before the situation requires it
Thoroughness: Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations

Quality Assurance Specialist Resume Examples & Samples

Test legacy and new test cases with the use of formal test cases/scripts. Execute smoke, regression and functional tests
Ability to size stories on Agile teams
Strong oral and written communication skills are essential, as well as follow-up and follow through skills to ensure issues are resolved in a timely manner
Add manual test to existing legacy plan

Quality Assurance Specialist Resume Examples & Samples

Responsible for quality assurance for all stages of software development lifecycle including requirement analysis, test plan development, and creating technical documentation for in-house developed software
Work closely with developers and customers and enforce quality at all level of software development
Work with the developers and customers to ensure that the technical requirements are well-understood from a testing perspective, documented and up-to-date
Responsible for quality of all components of the release (install package, technical and user documentation, etc.) including configuration management to ensure that all steps are clearly defined and documented to release SW to production environment
Conduct root cause analysis of identified defects, communicate to developers and other stakeholders to understand, replicate and resolve
Create client-side test environments to support the system test scripts (i.e. testing environments for multiple browsers, platforms, operating systems)

Quality Assurance Specialist Resume Examples & Samples

Work closely with Developers/Art Directors/Copy Writers/Content Managers/Producers and other groups inside an agency setting to deliver top notch digital quality
Ensure all things digital are properly tested using the latest in testing techniques and tools (manual and automated)
Passionate about all things digital, on the pulse of new technologies and strategies and the desire to bring these things into MullenLowe
Provide constructive feedback on the usability of all responsive and non-responsive website builds
Develop and deliver unique test strategies, test plans and test reports for each project (no two projects are the same)
Work in an agile environment delivering measurable successes during the life of a project
Document, track and communicate test plans, test cases, test results, and unresolved problems efficiently and effectively to the larger project team
Identify, analyze and document defects, questionable features, errors and inconsistencies within application of test
Conduct compatibility tests using multiple browsers, operating systems, hardware/software and network configurations
Execute functional testing, load and performance testing and conduct sanity and regression testing on relevant project
Work well with feedback, both internal and client based, able to pivot quickly to provide innovative solutions in a fast paced environment
Contribute to the vision and strategy of the Quality Assurance department, from implementation of quality assurance procedures and client solutions through to delivering supporting documentation
3+ Years working in a comparable QA role
Proficient testing on Mac or PC, also Mobile and Tablet devices
Advanced experience testing web based applications/websites/social media/video/audio
Expert communication skills, both oral and written, for both technical and non-technical audiences
Experience with test management tools such as JIRA, Selenium, Cucumber or Basecamp
A degree, ideally in computer science, and ISEB Foundation in Testing (Intermediate level) are a plus
Experience testing commercial websites in a digital creative and/or agency environment is plus

Quality Assurance Specialist Resume Examples & Samples

Measures employee performance via recorded monitoring and case audits
Measures process performance (gaps) via recorded monitoring and case audits
Analyzes trend report data from audits
Works with management on employee coaching, training and development to enhance or correct the behaviors that lead to excellent customer service
Assists with development of the contact centre training and QA process
Provide leadership and continued support to staff by answering questions, ensuring policies and procedures are being followed and reporting to Management observations and trends
Take inbound and outbound overflow calls when required
Ability to read and write clear and understandable instructions
Technical expertise with spreadsheet and word processing software
Experience in Procedure Development and Process Improvement
Must be able to use PC and have knowledge of Word, Excel and Outlook
Must be self-motivated, detail oriented
Must work with a high sense of urgency in a fast paced environment
Must be effective and efficient working in a team environment
Must be fluent in both English and French

Quality Assurance Specialist Resume Examples & Samples

Provide quality monitoring for teams in Owings Mills, MD and Martinsville, VA teams
Provide coaching feedback on the same day as monitoring
Ensure all data collected are in accordance with MD DHR requirements, confidentiality, and data quality policies
Support Training and QA staff as required in the classroom, via online resource updates and via various communication tools
Evaluate CSRs’ inbound/outbound interactions with customers
At least three years of experience as a CSR or six months of related quality assurance experience in a call center environment
Documented work experience in a customer service, or call center environment
Strong written and oral communication skills, both, required
Computer software programs proficiency including MS Office (Word, Excel, and PowerPoint) preferred
Proficiency and comfort with technology
Proven experience in reviewing individual performance and providing constructive feedback
Strong knowledge of CRM solutions
Experience in performance management, including talent evaluations, career development planning and providing constructive feedback in an effective and timely manner
Bilingual a plus: Able to demonstrate expert-level fluency in both English and Spanish
The ability to demonstrate a strong understanding of good customer service principles
Some understanding of data collection metrics and ability to apply those metrics toward targeted coaching
Experience with MD State Administrations such as the Family Investment Administration, the Child Support Enforcement Administration, Social Service Administration
Strong communication skills to include listening, verbal, interpersonal and written communication skills required
Attention to detail, problem-solving and decision making capabilities required
Team player with the ability to work effectively with all levels of staff in a fast-paced environment is a must
Ability to be flexible to handle multiple priorities and to work limited overtime as necessary
Including the ability to prioritize problems and situations in terms of strategic and possible long-term impacts
Strong analytical, problem solving, and decision-making skills
Ability to consistently deliver high quality customer service in a professional manner
Ability to maintain effectiveness and commitment when challenged by difficult situations
Ability to handle confidential and sensitive information

Quality Assurance Specialist Resume Examples & Samples

Quality Assessment (Associate): Demonstrates knowledge of standards of excellence for products and services within own area
Collaboration (Associate): Demonstrates understanding of how own role contributes to the team; seeks clarity in assigned responsibilities when necessary
Communication (Associate): Authentically communicates clearly and concisely with others
Customer Focus and Advocacy (Associate): Recognizes routine customer issues while understanding relevant project implications
Domain Knowledge (Associate): Demonstrates knowledge of the skills, tools and requirements needed to support projects within the domain; seeks opportunities to build domain knowledge
Root Cause Analysis (Associate): Analyses information in order to help identify the root causes of problems occurring at the project level
Risk Management (Associate): Collects and summarizes raw data to determine risk probability

Quality Assurance Specialist Resume Examples & Samples

To establish, organize and maintain a Quality Management System for a new DS manufacturing facility
Maintenance of the QMS (Quality Risk Management, SOPs, Change Control, Complaints, Recalls, Deviations, CAPAs, Investigations, PQRs, master documents)
Responsible for the management of GMP training and to foster a quality led culture across the new site
Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required
Oversee change control management process ensuring impact of proposed changes are adequately assessed how the implementation is managed
To conduct supplier audits, Internal audits and co-ordinate regulatory audits
Perform batch review and approval of release documentation
Perform QA inspection of production equipment and facilities
To support the onsite development function as required
To provide pre-and post-launch support for the rolling out and improvement of commercial activities
Review and evaluate technical reports from the development function
To manage the implementation of process improvements in line with the QMS
To review analytical, cleaning and equipment validation documents
Minimum BSc or similar/equivalent degree (Science/Pharma/ Biotech)
Minimum 6 years' experience in a QA Role
Must include role(s) within a manufacturing setting
Solid experience running cGMP systems
Sterile manufacturing and/or biotech experience is preferable
Pharmaceutical drug/process development experience preferable

Quality Assurance Specialist Resume Examples & Samples

BS degree in Computer Science, Engineering or a related subject
Proven working experience in software development and/or quality assurance
Knowledge of software QA methodologies, tools and processes
Experience with both black-box and white-box testing
Solid knowledge of SQL and scripting (Python experience preferred)
Experience working in an Agile/Scrum development environment is a plus
Strong verbal communication skills – oral and written
Attention to accuracy and detail
Strong, demonstrable work ethic

Quality Assurance Specialist Resume Examples & Samples

Work closely with software development team to understand the architecture of new and existing applications
Assist as needed in the development of test cases scenarios for end to end business user acceptance testing
Closely monitor prospect and customer facing applications to ensure performance is in accordance to tronc standards. These applications could be supported internally or externally
Stay connected with digital subscriptions industry best practices and research tools. Familiarize with other digital subscription paths. Provide recommendations that support overall tronc Acquisition and Marketing mission and goals
Multi-task and manage priorities to address production requirements in a very fast pace environment
Help coordinate testing task among other members of the department
Participate on daily/weekly scrums with internal and external customers during deployments
Bachelor’s Degree in Business or Technical field preferred
3-5 years of data quality assurance/monitoring experience
A keen eye for the design of effective, efficient and timely processes
Extremely high degree of accuracy and attention to detail
High regard for procedure and orderliness
An interest in technology and a passion for innovation

Quality Assurance Specialist Resume Examples & Samples

Candidates without a degree in a non-scientific field would be considered if there is prior experience in pharmaceutical investigations
Demonstrated knowledge of investigation or troubleshooting skills, ability to identify root cause and assign corrective and preventative actions
Demonstrated proficiency in communication skills both verbal and written
Demonstrated technical writing skill
Flexibility to changing work environment and deliverables
Standard business computer skills, MS Word, MS Excel, etc as required
Attention to detail/quality mindset

Quality Assurance Specialist Resume Examples & Samples

Experience with third party vendor management program execution
Detail-oriented and highly organized; thorough
Sound judgment and ability to determine practical applications of policy and standard requirements
Ability to identify prevalent themes and work with training team to enhance best practices materials and training guides
Strong work ethic and desire to work in a collaborative environment with direct team members and other GTO program vendor managers
Strong familiarity with Microsoft Office tools; especially PowerPoint, MS Word and Excel
Familiarity with SharePoint forms and navigation
Familiarity with business process management (BPM) tools and reporting considered a plus

Quality Assurance Specialist Resume Examples & Samples

System administrator for key electronic management systems (including Trackwise, product release system (QPR) and SAP) in order to maintain system operation and compliance
Participate in vendor assurance activities for the site, including leading vendor site audits and writing reports
Generate quality system metrics data to support various aspects of site and global QMS (including deviation management and Annual Product Quality Reviews)
Accountable for SAP material creation and amendment process
Provide QA support for routine site QMS activities (eg deviation management and change control)
Involved in the delivery of training to staff in site electronic system operation (eg Trackwise & QPR)
Represent QA on project teams – especially where electronic systems are involved
Provide support to the on-site Radiation & Radioactivity Calibration/Testing Laboratory (RRCL/RRTL) to define and manage QA policies and UKAS quality management system to ensure regulatory compliance
BSc in relevant technical field, or equivalent experience in relevant field or equivalent knowledge and experience
Experience in pharmaceutical or medical device industry
Experience with relevant pharmaceutical/medical device regulations and standards (eg GMP, ISO)
Experience of working within a quality management system
Experience with electronic systems (eg Trackwise, SAP, LIMs)
Proven ability in root cause analysis and problem solving
Ability to work independently in a fast-paced environment
Familiarity with relevant MS Office applications (including Microsoft Excel for generation of graphical metric data)
Experience with deviation management systems
Auditing experience or qualification

Quality Assurance Specialist Resume Examples & Samples

Batch record review and product release
Participates in the development and maintenance of Quality System metrics
Supports the preparation and execution of Quality Management Reviews at the site and P&L &GEHC levels
Bachelor's Degree or significant work experience
Ability to communicate effectively in German and English (both written and oral)
Technical or scientific education, qualifications in quality management preferred
Oracle skills desired
Relevant experience in a regulated industry is preferred
Statistics education and/or training
Ability to identify root cause of an issue, and creatively problem solve to gain resolution
Ability to work independently in fast-paced environment with little supervision
Ability to adapt to constant change and influence positive change effectively
Team-oriented and responsive to customer needs

Quality Assurance Specialist Resume Examples & Samples

Act as QA representative on project teams
Monitor project compliance to standards and guidelines
Generate QA resource estimates
Verify that project documentation is sufficiently detailed to support development of QA materials
Develop product test plans, test scripts and checklists
Coordinate appropriate test environments, equipment, etc
Perform integration, functionality, system, regression, load and acceptance testing using manual methods and testing tools
Perform server log file and database verification
Perform business and functional requirements verification
Detailed verification of product content and presentation
Record all test results, and completely document defects and system errors
Continually search out new technologies and processes to improve QA functions
Some administration of testing and QA tools
Training and mentoring others in the use of testing and QA tools and processes
At LEAST 1 year experience in the following
Software test automation tool (s)
Formal software test methods and Quality Assurance programs
Preparation or formal test plans, test cases and bug reporting
Formal testing techniques such as regression, integration, load, usability, etc
Web testing experience
Meticulous nature; displaying a penchant for detail and precision
Exceptional teamwork skills, sense of humour and a positive attitude
Experience with web development (HTML, CSS, Javascript, and such)
Experience conducting or facilitating walkthroughs and inspections
Unix knowledge
Formal software testing training or certification

Quality Assurance Specialist Resume Examples & Samples

Interpret and implement quality assurance standards
Monitor procedures and recording and reporting quality data
Develop, recommend and monitor corrective and preventive actions
Identify training needs and assist in training to meet quality standards

Quality Assurance Specialist Resume Examples & Samples

ISA Arborist/Utility Specialist certification
Auditor certification (ASQ, RAB, IIA)
Utility experience, including general knowledge of the utility industry and utility operations in a regulatory environment
Strong communication skills for all levels of organization, both verbal and in writing
Ability to manage multiple competing priorities to completion
Ability to multi-task and meet critical deadlines while delivering high quality work products
Accomplished in the use of MS Office suite including Word, Excel, Power Point, Visio and Access. Other application experience such as PG&E VM applications
U.S. Armed Services Veteran

Quality Assurance Specialist Resume Examples & Samples

The ideal candidate will work on multiple projects in support of project managers to ensure that code, contract, and regulatory requirements are translated into the project engineering design documents prior to final review by the Nuclear QA Manager
Develop and perform analyses of engineering studies, drawings, and specifications
Work closely with the Nuclear QA Manager to provide guidance in applying the QA Program with QA/QC, field engineers, and project managers
Perform inspections, surveillances, audits, and assessments as needed
Review in-coming, in-process, and final design documents including detailed inter-disciplinary reviews of mechanical, civil, structural, electrical, process instrumentation and control drawings, diagrams, specifications, calculations, and equipment lists
Perform quality assurance activities such as: project trend analysis, vendor and project inspections; testing oversight and monitoring for compliance with specifications for design and construction of all mechanical, civil, instrumentation control and electrical requirements of the contract and design; conduct internal and external surveillance of the contractor's proposed quality control system and implementation thereof; and review technical documents, test plans, test procedures and test reports and submissions for completeness, technical adequacy, and compliance with design deliverable, construction contract requirements and applicable regulations
Lead all quality-related activities, including regular review of construction quality plans and quality level and functional classifications of structures, systems and components; and draft monthly quality dashboard performance monitoring metric reports of leading and trailing quality performance indicators
Assist in the review of purchase orders and subcontracts including defining the requirements for flow down of the appropriate quality assurance/quality control requirements to contractor's proposal
Ensure all issues are appropriately logged in the QA project tracking system

Quality Assurance Specialist Resume Examples & Samples

Knowledge of the values and practices that align customer needs and satisfaction as primary considerations in all business decisions, and ability to leverage that information in creating customized customer solutions
Knowledge of major products and services and product and service groups; ability to apply this knowledge appropriately to diverse situations
Knowledge of, and experience in management of the development, delivery and maintenance of technology product documentation and publications

Quality Assurance Specialist Resume Examples & Samples

Performs analytical testing of all materials and finished products samples
Ensures that outlier samples are identified and sent to wet chemistry lab for verification other related purposes
Operates and maintains NIR analytical equipment
Ensures that all incoming deliveries are sampled, checked, and logged properly
Performs grinding, microscopy testing, and minor chemical tests when needed
Maintain safe work environment and performs regular housekeeping of work area
Graduate of a bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy or other related courses
With at least one (1) year experience working in a laboratory set up for a manufacturing company
Knowledgeable in various analytical wet chemistry test and instruments. Should have a strong problem solving, decision-making, and organization skills,
Should have an ability to recognize patterns in the analyses being undertaken in the laboratory that will serve as a tool for proactive spotting of problems in quality
Proficient in various software programs such as MS Word, Excel, and PowerPoint
Willing to work in Villanueva, Misamis Oriental

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance resource supporting activities and initiatives related but not limited to operational functions and materials control. For example, involvement in activities related to re-work, in process inspections, document / records reviews and product release
Support activities, as needed, related to customer complaint investigation and sample / product analysis process
Support and serve as a resource for quality issues including but not limited to nonconformance failure investigations, assisting in establishing scope or extent of non-conformances (bounding/bracketing), assist in determination / completion of risk assessment, rework activities and product release
Provide Quality Assurance support for EES-Albuquerque operations
Maintain knowledge of all procedures, change to specifications (Process, Training Manuals, Material Specifications, etc.), and regulations related to their area of responsibility
Maintain process knowledge for the assigned area of responsibility
Manages varying circumstances and changing conditions as multiple situations may have to be addressed at the same time
Participate in implementation of the EMS management system including continual improvement, pollution prevention, objectives and targets, and regulatory compliance
A minimum of a High School Degree, GED, or equivalent required
A minimum of two (2) years of experience within manufacturing operations, preferably in the medical device industry preferred
Knowledge of product and process specifications preferred
General knowledge of medical devices preferred
Knowledge of Good Manufacturing Practices (GMPs) and ISO (International Organization for Standardization) policy and procedures preferred
Basic computer skills and use of software applications requirement
Physical demands require long walking, standing, bending, stooping and reaching. May require lifting of boxes or material not to exceed 50 lbs. May require use of a pallet jack. Maintain vision certification through the visual acuity testing/process. Office deskwork, requiring sitting, walking, using the phone and computer
Ability to work 3rd Shift which is Sunday – Thursday (typically 11:00pm – 6:30am) required
Ability to work overtime, support different shifts, weekends, and select holidays required.Quality Control

Quality Assurance Specialist Resume Examples & Samples

To establish, organize and maintain a Quality Management System for a new manufacturing facility
Responsible for the management of GMP training and to foster a quality led culture across the site
Support validation activities

Quality Assurance Specialist Resume Examples & Samples

2-3 years relevant experience in a health plan environment is required
Experience with a multi-faceted sales organization and/or a quality assurance role is preferred
Must be able to demonstrate initiative in project-related activities and act independently as needed
Excellent interpersonal and listening skills with a positive attitude and an openness to learning while helping to effectuate change
Must be analytical, organized, detail-oriented, and dependable
Excellent proofreading skills and attention to detail a must

Quality Assurance Specialist Resume Examples & Samples

Coordinate the program’s Quality Assurance Program, processes and procedures according to program requirements and industry best practice
Work with Stakeholders to establish quality expectation and quality plans for the Program
Consult and coach project teams to integrate quality management activities into project plans
Identify, analyze and prepare risk mitigation tactics; track and report issues
Define, analyze and present appropriate quality metrics as part of the continual service improvement lifecycle
Recommend process improvements in order to maintain quality regarding contractual and organizational requirements
Gather and correlate information concerning policies, systems, procedures, forms, and reports among all locations and departments
Analyze existing procedures and methods to promote effective operations through standardization, improvement, simplification, and discontinuance
Identify and analyze quality assurance trends and refer any realized issues to management
Experience and knowledge of quality management principles, methodologies and tools
Experience working on quality management programs in large system integrations
Experience applying Quality Assurance processes to software and IT infrastructure programs
Experience determining process measures and tracking to determine process effectiveness and efficiency
Experience planning strategies and tactics; analyzing problems and determine root cause, generating alternatives, evaluating and selecting alternatives and implementing solutions
Experience being flexible in response to changing requirements such as surges
Experience with Agile and Waterfall delivery
Bachelor’s degree in Math or related technical field or the equivalent experience and up to two (2) years of related experience required

Quality Assurance Specialist Resume Examples & Samples

Are creative and innovative at their core
Like to be involved in the details
Work with others toward full systems integration of the deliverable
Likes to be involved at the beginning and see projects through to the end
Are focused on customer and team success
Can juggle multiple projects at various stages of maturity

Quality Assurance Specialist Resume Examples & Samples

Participates in the reviewing of engineering designs to contribute quality requirements and considerations
Assists product support areas in gathering and analyzing data
Bachelor’s degree and 2+ years related experience

Quality Assurance Specialist Resume Examples & Samples

Responsible for development of project Software Quality Assurance Plan and the implementation of procedures that conforms to the requirements of the contract
Responsible for verifying that each functional component of the software project follows a defined process which is in conformance with contractual requirements
Reports findings to project staff, line management of the organization, and the customer, as appropriate

Quality Assurance Specialist Resume Examples & Samples

Develop,apply, revise, and maintain quality standards for receiving, in-processing, andfinal inspection in accordance with company and contractual requirements
Reviewprogram CDRLs, enforcing quality standards and procedures for program documentsand records
Writeinspection procedures
Review andevaluate in-process rejections and implements corrective action as needed
Participatein audits
Experiencewith ISO 9001:2008
Experiencewith CMMI-ML3
MSplus 5-7 years
BSplus 7-9 years
HSplus 13-15 years

Quality Assurance Specialist Resume Examples & Samples

Evaluate soft/hard prototype samples and production test runs ensuring conformance to requirements
Document evaluation results in quality management system
Measure, record, and define tolerances for critical parameters
Provide technical support for New Product Engineering and Manufacturing throughout the new product development process
2 plus years QA and/or manaufacturing experience in soft/hard goods
Graduate Gemologist, Advanced education in technical area

Quality Assurance Specialist Resume Examples & Samples

Prior experience writing test scripts - Required - 5 Years
Prior experience executing test scripts - Required - 5 Years
Prior experience using Microsoft Test Manager - Required - 3 Years
Prior QA experience within Agile Methodology - Required - 4 Years
Prior experience with Black box testing - Required - 4 Years
Prior experience with Workflow application testing Required - 4 Years
Prior experience beginning the project as a tester in the pre-production stage Required - 4 Years
Prior experience starting a project in the middle of testing cycles Required - 4 Years
Prior experience working with Legislative IT systems Highly desired - 1 Year
Prior experience using Team Foundation Server - Nice to have

Quality Assurance Specialist Resume Examples & Samples

Meet daily, weekly and monthly transaction monitoring goals in order to provide detailed, timely and accurate evaluations for each of the support team members
Communicate QA feedback issues to operations Team Leaders & Manager. Coordinate closely with team leaders and/ or managers on quality performance management
Set and spearhead clear process improvement plans. Explore possible improvements to the department’s quality assurance key initiatives. Implement, and continuously improve on a QA process flow that will ensure compliance and improve quality of communication and correspondence
Represent the quality function in critical meetings, calibrations and drive the delivery of all quality action items in conjunction with Operations and Training
Act as subject matter expert on product knowledge and program updates, facilitating hand-off of feedback for training requirements (Process updates, refresher courses or remediation, etc)
Coordinate and assist Training and Operations in agent development during the “Nesting” or on-boarding period
Track end customer feedback and be able to recommend solutions or create action plans to address them
Other duties as required by business needs

Quality Assurance Specialist Resume Examples & Samples

4 years of Proficient in computer programming concepts (Required)
4 years of Proficient in programming with the PHP language (Required)
2 years of Experience with MySQL (Required)
2 years of Understanding of the MVC architecture model (Required)
2 years of Must be able to identify problems with code and create a patch and release patched application (Required)
1 years of Knowledge of code versioning and merging (Required)
1 years of Experience with AJAX (Highly desired)
1 years of Experience with JQuery (Highly desired)
2 years of Experience testing (Required)
2 years of Experience with Automated Testing and Tools (Required)

Quality Assurance Specialist Resume Examples & Samples

Maintain oversight of the incoming batch documentation binders to ensure goods are being
Starters are welcome to apply, 1-3 years of experience in a quality and production environment is an asset
Good analytical skills and knowledge of problem solving techniques
Team player with speak up mentality
Ability to work both independently and with a team in a collaborative setting
Knowledge of the English and Dutch language (both oral and in writing)
Familiar with Microsoft Office
Customer first mindset
Knowledge of Six Sigma tools and SAP is an asset
Knowledge of quality standards (for example CFR 21 part 211, CFR 21 part 820, ISO
9001:2008, ICH Q8, 9, 10, ISO 15378:2011,…) is an asset
Excellent organizational skills along with strong attention to detail and time management

Quality Assurance Specialist Resume Examples & Samples

Lead the establishment & maintenance of systems and tools such as Change Control, Deviation, Audits and Inspections, and Customer Complaints to support the various business processes on site in full compliance with predicate rules and Novartis internal requirements
Train site personnel on such systems and act as a key user / system administrator for such systems on site
Lead and coordinate the supplier and service provider qualification, related audits and QA Agreement programs for the site ensuring timely completion of activities to meet Novartis and regulatory requirements
Ensure that during the project phase all activities related to establishing manufacturing processes for Drug Substance comply with cGMP and applicable regulations and Novartis Quality Manual
Participate as a representative of the Operational QA in project teams (e.g.: Master Batch records, equipment, cleaning and process validation)
Manage quality issues and investigations (e.g. deviations; trends, OOS) with the respective departments and ensure that they are tracked to completion
Perform review of GMP relevant documents for compliance with SOPs across several customer groups (e.g. TEDI documents, SOPs, documents etc.), including filing and archiving documents owned by QA
Prepare, review major system documentation to ensure consistency with quality standards and quality of deliverables, related to department activities and other departments
Coordinate within site and with relevant global Novartis group/s with respect to implementation of Novartis Pharma Corporate Quality Manual, Policies and any other legislative requirements on site

Quality Assurance Specialist Resume Examples & Samples

Maintains awareness of activities by routine direct observation of Cell Production suites and facility. Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support system. Address conditions/practices with appropriate personnel, documents and reports findings to Management
Performs Equipment Validation review and approval
Writes and revises SOPs as necessary
Participates in label preparation and inspection for cell bank and cell therapy processes
Participates in quality and process improvement initiatives and project teams
2-4 years’ experience
Ability to record data accurately and legibly

Quality Assurance Specialist Resume Examples & Samples

Maintains awareness of activities by routine direct observation of testing laboratories. Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management
Compiles and reviews Testing batch records in accordance to cGxP and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
Participate as needed to support internal audits
Education Required: BA/BS degree in a Science related major
Years of Experience: 2-4

Quality Assurance Specialist Resume Examples & Samples

Fit apparel on body form to confirm fit, identify inconsistencies, and make fit recommendation
Enter measurements, fit recommendation, and descriptive product details into PDP
Identify and submit vendor problems and clear documentation to Vendor Ops for resolution
Perform expanded QC checks as needed
Identify appropriate level of QC check required utilizing FIFO and priority level to maintain process flow
Work with Product Launch to ensure all priority merchandise is QC checked and update Special Launch Tracking spreadsheet
Monitor the queue and Receiving watch list to follow up on pending styles
Bring urgent issues to managers attention for input and direction

Quality Assurance Specialist Resume Examples & Samples

CMO vendor management
Internal and external audit support
Third party and regulatory inspection participation and support
Batch record review
Process validation, equipment cleaning, and technical transfer support
Quality presence- ongoing vendor calls and site visits
Participate in Product Complaint investigations, Annual Product Review, Material, Supply and Change Control Review Boards as needed
Manage and oversee Quality Systems including deviation, quality investigation, change control, product complaint, and CAPA
Assist and collaborate with other department such as Technical Operations, Quality Control, Clinical Compliance, Quality Assurance Systems, Regulatory, and Pharmacovigilance to ensure continued compliance, product quality, and patient safety
Support additional functions, processes and systems as related to product SISPQ
A minimum of a B.S. degree in science/engineering, or related field, with at least 5 years relevant experience in a CMO, CRO or sponsor environment
Quality-focused experience with sterile injectable products, solid oral formulations and/or Class II medical devices
Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, and EMA regulations as related to pharmaceutical and medical device manufacturing
Prior experience with Quality Systems, specifically Product Complaint
Quality-focused experience with sterile injectable products, solid oral formulations, Class II medical devices, and combination products
Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, Health Canada and EMA regulations as related to pharmaceutical, medical device, and combination product manufacturing

Quality Assurance Specialist Resume Examples & Samples

Provide staff support regarding quality systems, including maintenance of logs, facilitating timely closure of records and providing QA review as appropriate
Support resolving system related issues, and ensuring records are processed according to procedures and guidelines
Facilitate the document change request process, including providing formatting assistance, coordinating the review/approval process, tracking and routing of controlled documents
Maintain electronic and hardcopy history files of controlled documents, ensuring accurate and reliable filing systems
Assist with preparation of Quality metrics and reports
Review equipment records and work closely with internal departments, ensuring that calibration and maintenance activities are performed in compliance with SOPs
Prepares quality metrics and report. Initiates updates and creation of new SOPs as required
Copy, scan, and distribute controlled documents as needed. Issue, track and/or reconcile controlled test record forms, logbooks and laboratory notebooks
Minimum of a Bachelor"s Degree in a Life Science or other relevant discipline with a minimum of 2+ years of work experience in the pharmaceutical industry
Previous Document Control or Quality System experience is required, preferably 2+ years in the pharmaceutical industry
Experience with the quality systems is desirable
Must be proficient in MS Office (Word, Excel, PowerPoint) and Adobe Acrobat
Knowledge of GMP regulations is required
Must be able to communicate well with all levels of staff, work independently and pay attention to detail
Ability to manage and prioritize multiple projects/tasks, with minimal supervision, and adapt to changing priorities

Quality Assurance Specialist Resume Examples & Samples

Ensure compliance with CGMP regulations and company procedures for drug product packaging and labeling operations
Review and approve batch documentation associated with packaging and labeling of medicinal products such as executed batch records, label proof and label text, and other documentation as needed
Release (or reject) packaged/labeled supplies for clinical use as per schedule. - Review procedural documents
Participate in the conduct of investigations into deviations and the review of investigation reports and CAPAs
Participate in the monitoring program as needed
Minimum BS in Life Science with 7-9 years of relevant experience within the pharmaceutical or healthcare industry; or MS with 4-6 years of experience including 2-4 years of experience in a regulated function
Requires thorough knowledge and understanding of CGMP regulations
Practical experience in packaging and labeling operations of medicinal products is preferred
Ability to proactively identify key issues and interact constructively in a team approach to problem solving
Excellent judgment, strong organization, and communication skills are needed
Serve as key interface with GMP operational groups across Pharmaceutical Development
1603595

Quality Assurance Specialist Resume Examples & Samples

Compiles and reports quality metrics on a periodic basis. Highlights trends and potential opportunities
Conducts product audits on new and existing items to measure compliance to requirements. Summarizes data, identifies concerns and provides feedback to key stakeholders
Follows up pending corrective actions from suppliers and maintains up-to-date information on Supplier Management System
Maintains QA and Company product information databases and critical files
Monitors Customer Complaint database and reports both immediate issues and longer term trends on a routine basis
Supports cross-functional project teams to ensure business initiatives and/or new market openings meet Quality, Product Safety and Regulatory Standards
Supports investigation and troubleshooting of quality, food safety and/or regulatory issues arising from partners, customers, retail stores or regulators. Supports implementation of corrective actions and procedure improvements to resolve issues
Supports review and/or updating of company operating procedures, training programs, resource manuals, standards manuals and operational tools related to food safety, sanitation and regulatory compliance
Supports the documentation, implementation and updating of Quality Assurance operating procedures
Utilizes department procedures to audit and qualify supplier and distributor QA programs to assure that quality, safety and regulatory compliance standards are met for ingredients, products and supplies. Identifies compliance issues and works with suppliers and distributors to resolve
Utilizes department procedures to gather and review product information from suppliers worldwide. Assures accuracy, completeness and reasonableness of information. Follows up with suppliers to resolve problems
Food Safety Certification classes including safe food handling and sanitation (2 years)
Gathers, records and reports on operational and quality metrics(2 years)
Manufacturer/Supplier quality system and product quality auditing (2 years)
Plans, develops, monitors and verifies Quality System programs and processes (2 years)
Uses product formulas and product information to create required label information, including nutritional information (1 year)
Degree in Food Science, Biology, Chemistry, Environmental Science or related field or equivalent experience
Understanding of GFSI and related auditing schemes

Quality Assurance Specialist Resume Examples & Samples

Review and approve manufacturing master batch records, executed batch records, in-process/finished product quality control data for timely disposition of drug product intended for human use
Prepares lot disposition reports, reviews planned changes, deviations, analytical reports, laboratory investigations, change controls, method and process validation protocols and reports for management review
Review and improve existing quality procedure workflows and identify areas of improvement for efficiency. Draft or revise applicable written procedures
Participate in tabulation and assessment of departmental and global metrics as well as Annual Report compilation for Commercial Drug Products
Interface directly with contract manufacturers, Alliance partners and manage quality related issues by leading investigations and identifying corrective actions
Interact with Manufacturing, Quality Control, Materials Management and Regulatory Affairs personnel to ensure that commercial drug products are manufactured and tested in accordance with established procedures
Provide direct support to assigned product leads to ensure MOH levels are maintained ensuring commercial supply
Some domestic and international travel required (~30%)
Good working knowledge of Quality Systems, ICH guidelines and CGMP standards applicable to commercial Drug Product (21CFR 210 and 211). and knowledge of European regulations
Experience in Medical Device is desirable
An accountable team player who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures
Excellent attitude and strong multitasking skills
Ability to adapt to changing priorities and timelines and work well in high pressure environments
Working knowledge and expertise in manufacturing and/or testing of sterile products
Possess critical thinking skills when making sound quality decisions based on risk management and available data

Quality Assurance Specialist Resume Examples & Samples

Provide continuing support for development, implementation and maintenance of the HPIL Pharmaceutical Quality System and supplier management program
Provide support for management of complaints, deviations, CAPA’s and change controls associated with commercial products
Provide operation and maintenance support of quality documentation system
Support the preparation and delivery of training on Quality related systems, procedures and processes
Support the preparing and compilation of HPIL quality metrics for monthly report
Support preparation activities for review of the HPIL PQS and management review
Support supplier qualification and internal quality review
Support Investigating out-of-trend/specification (OOT/S) reports
Support conducting of internal audits and/or coordinating the HPIL self-inspection program
Work directly with other key Company departments to ensure compliance and productive working relationships
Maintain up to date Quality Technical Agreements with all GxP vendors and take on other activities/responsibilities as required due business needs
Bachelor’s degree in chemistry, biology or a related discipline is desirable
Experience with out of spec investigations, change control
Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
Experience working with contract manufacturing sites or virtual manufacturing is desirable

Quality Assurance Specialist Resume Examples & Samples

Follows new product introduction related plans keep connection with Launch Managers
Requests documentation from suppliers and track those availability
Coordinates review process of documentation, ensures continuous feedback to suppliers during new product implementation
Prepares the pre-launch list and get it approved by the Qualified Person
Follow up the completion of quality assurance related action items of new product implementation related change controls
Maintains list of Mylan Komárom New product Implementation index after approval of new product
Files new product related documentation and ensures those availability
Master/Bachelor Degree as Pharmacologist, Chemist, Chemical Engineer, Biologist, Biological Engineer, Environmental Engineer, Food Industrial Engineer, Computer Science or similar degree,
Good problemsolving and decision making ability
Reliability, accuracy
B2 level of English knowledge,

Quality Assurance Specialist Resume Examples & Samples

Requires a 4 year degree in a scientific field
Must have knowledge of regulatory requirements in support of non-clinical, clinical, manufacturing and/or device work
Demonstrated effective communication skills, both written and verbal
Working knowledge of MasterControl or other Quality Management Software Systems preferable

Quality Assurance Specialist Resume Examples & Samples

Responsible for the final quality check for Utilization Dashboards and 90 Day Business Reviews for new, non-regularized employees
Completes QC checks for other case types on an audit basis to ensure deliverables are of the upmost quality
Absorbs and applies new operations procedures swiftly and correctly
Serves as a back-up Lead and Queue Master to manage the case workload and escalations if the Lead is unavailable
Interpret client contract terms; validate billing amounts against the contract terms
Utilize tools and systems proficiently to track activity and ensure knowledge base integrity
Review data from multiple sources to insure accuracy and applicability to context of request
Work cross-functionally to research disputes and/or escalations to gather supporting documentation along with compiling a historical framework to support decisions and correction actions
Interact closely with Client Development, IT, R&D, Support, Finance, and Implementation teams
Maintain a strong passion for solving problems and helping internal and external customers
Escalates unresolved issues as necessary to ensure timely response
Other duties as assigned by manager as needed. Responsibilities will likely expand as the team expands
Experienced quality auditor with success in providing quality form and structure
English fluency required
Two or four year college degree
Minimum of two years of experience in a fast-paced client services organization
Effective interpersonal and communication (oral & written) skills required
Good knowledge of grammar and spelling
Capacity to work co-operatively with others to achieve results
Informs manager of consistent quality concerns for coaching and training
Attention to detail and deliverable timeliness
Proactively manage multiple tasks
Prioritizes the most important tasks and placing attention, energy & focus accordingly
No current attendance issues; regularly comes to work on time and ready to work
Tools knowledge
Working knowledge of word processor and spreadsheet programs (i.e. Excel, Word and PowerPoint)
Experience working in a CRM such as Salesforce
Experience working with Reporting tool, such as Cognos
Knowledge of the business travel industry or of standard accounting processes is desired but not required

Quality Assurance Specialist Resume Examples & Samples

Maintain a thorough knowledge of Alorica’s programs, policies, and technology. Monitor calls and provide coaching and feedback
Maintain accurate and sufficient documentation of agent calls including positive observations, as well as areas of needed improvement
Provide ongoing QA Call Evaluations to the appropriate Operations Manager/Supervisor
Prepare reports; create Quality Tips, etc
Report daily, weekly and monthly quality results
Report results to center and corporate management
Recommend changes necessary to ensure quality performance. Provide quality result information on QA candidates for posted positions
Work in conjunction with training to ensure QA participation with new programs, new hire classes on existing programs and/or changes to programs. P
Anticipate in on site client review meetings including the development information on quality performance on assigned programs

Quality Assurance Specialist Resume Examples & Samples

Bachelor's degree or equivalent and relevant formal academic/ vocational qualification in a clinical CAP/CLIA or other regulated laboratory
ASCP Medical Laboratory Technologist Certification highly preferred. A college degree in chemistry or related science or an equivalent combination of education and experience
Previous experience that provides the knowledge, skills, and abilities to perform the job(comparable to 5+ years) or equivalent combination of education, training, and experience
Expertise in one or more specialized areas relevant to QA activities, e.g. computer systems, root cause analysis, TQM, QC troubleshooting, CAP/CLIA guidelines, and a history of implementing Analytical Measuring Range and proficiency testing process
Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits
Knowledge of chromatography, immunochemistry or statistics is required
Thorough knowledge of GxP and appropriate regional research regulations and guidelines to high standards required by management
Strong understanding of Quality Control Levey-Jennings charts and Westgard Rule

Quality Assurance Specialist Resume Examples & Samples

As needed, assist with complaints, CAPA, change requests, NCMRs, deviations
Provide support to QA activities for regulatory compliance, (i.e. Management Review support, regulatory audits)
Work with managers to coordinate training requirements for employees
Assist with managing the training program
Assist with internal audits and agency audits
Perform Document Control activities as needed such as processing documents and filing
Review and disposition batch records
Review Raw Material Specification
Maintain equipment/calibration files and log

Quality Assurance Specialist Resume Examples & Samples

Acting as the subject matter expert the specialist shall support setups with customers, coordinating with stakeholder’s critical information necessary for input into the UDI databases
Leading and/or contributing to Quality Assurance process improvement projects
Advises management on best practices required for creating, issuing, reassigning/decommissioning UDI numbers, and assuring that data integrity is met Advises management on best practices required for creating, issuing, reassigning/decommissioning UDI numbers, and assuring that data integrity is met
Submitters, and working closely with GS1 on obtaining Global Identifiers
Supporting external agency and internal audits as needed
Maintain Quality metrics as required
Support training program
Support complaints management
Perform Document Control activities as required
Review and release batch records as required
Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc

Quality Assurance Specialist Resume Examples & Samples

Translates Quality Assurance strategy into tactical plans and ensures implementation
Utilize knowledge of/experience with ISO 9001 develop, document, implement, test, maintain, and continuously improve project quality
Develop and maintain a contract-level Quality Manual that details the maintenance of an inspection system acceptable to the government. Provide framework for standardizing Corrective Action processes and procedures
Maintain records of inspection that are available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract
As needed, interface with Government representatives during surveillance of the contract
Perform internal audits on contract operations to ensure compliance with contract deliverables. Utilize appropriate techniques to gather, identify, test and classify objective evidence and metrics of performance
Assist project staff in development of and compliance with project procedures

Quality Assurance Specialist Resume Examples & Samples

Perform hands-on QA including new features testing, regression and load tests
Create and execute automated verification scripts
Coordinate system testing efforts across local and offshore teams
Lead the software releases verification and sign-off process
Write test documents including test plan, test cases and test summaries
Provide management with status reports and updates
Participate in the design process to ensure QA deliveries

Quality Assurance Specialist Resume Examples & Samples

Perform review of contacts from all channels to ensure adherence to quality assurance standards
Identify agent performance improvement opportunities through contact evaluations and provide feedback to agents through coaching
Assist with QA coaching, documentation of feedback provided and tracking behaviors coached
Work with contact center team leaders to drive a continuous improvement culture across the department
Work with the QA Manager to identify performance improvement opportunities by analyzing quality data and coaching documentation
Participate in QA calibrations, and identify process improvement opportunities relating to contacts, agent behavior and internal knowledge base gaps
Provide management with observations and trends identified during contact review
Assist with QA ad hoc projects, create reports and deliver in a timely manner
Works with the QA Manager to provide support and guidance for current Quality Staff in the network
Assists with coordination of QA efforts at the local sites
Completes sprint projects requiring contact reviews and summarizes findings
Bachelor’s degree or equivalent in related field
Minimum three years of contact center experience to include one year of contact center quality assurance
Experience in phone, chat and email contact centers preferred Intermediate level Microsoft Office skills (Excel, Word and PPT)
Basic knowledge of call recording software
A capacity to focus for long periods of time while reviewing contacts
High level of attention to detail and a talent for organization
The ability to see the big picture as it relates to QA and Customer Service operations
Able to comfortably present in front of large and small groups
Able to build solid relationships with local leaders and demonstrated ability to work well in a fast-paced team environment
A proven ability to work autonomously and a capacity to self-direct
Able to effectively execute and drive change across multi-cultural environments
Has the capacity to drive small initiatives that require some technical knowledge relating to software and features in addition to internal contact tagging tools
A high level understanding of Audible CS operations and products
An high level of understanding of Audible CSC systems
A proven understanding of Audible app technology

Quality Assurance Specialist Resume Examples & Samples

Minimum BS degree in technical area and 3-4 years of experience. Or 6 years related experience within a pharmaceutical, biotechnology or related industry
Must have proven record of excellent organizational, oral and written communication skills
Must have good word-processing skills and familiar with office software, i.e. MS Word, Excel, Power Point, etc
Requires occasional bending, stooping, kneeling, crouching, reaching above shoulders and below knees, and lifting up to 50 pounds consecutively
Demonstrated ability to multi-task, prioritize, and meet deadlines
Demonstrated ability to handle routine tasks timely, accurately
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records

Quality Assurance Specialist Resume Examples & Samples

Audit department processes for accuracy and timeliness
Assess department weaknesses based on audit results
Review user-level software, training materials and instructions and assist training to internal billing department on updates/enhancements
Perform audits of Velocity Resident Billing output, provide associated reporting. and make recommendations to improve quality
Perform audits of Velocity Resident Billing Implementation configurations, provide associated reporting. and make recommendations to improve quality
Maintain records on resident billing quality for each employee involved in the billing process. Ensure that clients can see their portfolio’s quality report on a timely basis
Work closely with the department Trainer to deliver instruction in quality aspects and in reinforcing the quality practices through training
Assist Velocity billing department employees with product and process questions as needed
Serve as subject matter expert for Resident Billing department
Report software defects to development
Participate in requirements definition and design review meetings with product development team
Bachelors degree preferred; equivalent experience may be considered in lieu of degree
Minimum of 1year experience in Velocity Resident Billing department; equivalent experience in billing or related quality specialist role may be considered in lieu of internal Velocity experience
Strong written and verbal communication skills required; must be able to effectively communicate between customers, staff and management
Excellent organizational abilities essential; strong attention to detail
Above average interactive, planning, time management skills
Demonstrated ability to develop, evaluate and motivate others
Good working knowledge of Word, Excel, Outlook and the Internet Explorer
Able to stand for extended periods of time during training sessions
Ability to work extended hours if needed

100

Quality Assurance Specialist Resume Examples & Samples

Project Development - Collaborative development with the other disciplines within information systems (development, business analysts, database, and multimedia)
Organization and Interpersonal Skills - Ability to deal with and balance multiple priorities
Proven ability to communicate information and ideas in spoken or written form so that others will understand
Thorough understanding of the software lifecycle and relevant software methodologies used in software development

101

Quality Assurance Specialist Resume Examples & Samples

A minimum of 6 years of experience including at least 2 years of design and 1 year of working drawing experience
A BSE is required; a BS/BA in a technical/non-technical field can be substituted provided that personnel meet all other requirements and have at least 5 years within the 6 years required of work experience directly related to the position. In lieu of a degree and 6 years of experience, 12 years of related work experience in a related engineering discipline can be substituted for personnel not having the required degree
Must possess the skills and ability to effectively communicate both orally and in writing
Must possess and exercise diplomatic tact and interface with the customer
Must be proficient in the full suite of Microsoft Office products and tools
Travel (10%) may be required

102

Quality Assurance Specialist Resume Examples & Samples

Review and approve IT Change Controls
Lead or contribute to site IT Audits to ensure compliance to regulatory guidance and to Catalent policies and procedures
Contribute to ongoing quality initiatives, metrics and compliance enforcement
Keep current with applicable regulatory guidance and industry approaches
BA, BSc or equivalent in relevant discipline is required
5 to 10 years within the Pharmaceutical or related industry, which includes a minimum of 5 years in an IT, Quality, Regulatory and or Operations (Laboratory, manufacturing, packaging) role is required
Advanced communication skills in the English Language is required
Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance
Appropriate leadership skills and behaviors aligned with Catalent competencies and values
Must demonstrate organizational skills and be able to interact with personnel at all levels within the organization from a variety of cultural backgrounds
Must be a self-starter, able to work independently in a remote none office based role and have ability to multi-task under strict deadlines
Detail orientated with ability to accomplish objectives through clear thinking and strong personal organizations skills

103

Quality Assurance Specialist Resume Examples & Samples

Assures GDP (Good Distribution Practices) in a warehouse environment
Subject Matter Expert on determination of a deviating event versus comment
Participate in events on the warehouse floor when they arise
Work directly with others (warehouse staff, PTS) to ensure immediate QA swarming of events
Work with QA peers and others to determine if forward processing can continue and ensure documentation of this justification is in TrackWise
Participate and run daily Triage meetings
Review level I deviations to ensure compliance to Shire procedures
Work with deviation initiator to ensure deviation intake is clear and all viable information is gathered
Actively work with warehouse personnel and QA peers to help reduce deviations
Work with management and peers to ensure a robust handoff of all LII/LIII deviations to the QA Operations (Compliance) Team
Responsible for adhering to cGMP regulations and Shire policies
Assures cGMPs and company procedures are followed and, if needed, procedures/policies are revised

104

Quality Assurance Specialist Resume Examples & Samples

Database familiarity with data entry/searches / queries
Accurate data entry skills. Attention to detail
Ability to meet deadlines
Organisational & planning skills
Ability to work in team and solo capacity
Some knowledge of batch auditing is preferable although not essential (e.g. has carried out production reviews of batch paperwork)
Basic Scientific Knowledge

105

Quality Assurance Specialist Resume Examples & Samples

Ability to meet deadlines in a fast paced work environment driven by complex software systems and processes
Intermediate to advanced knowledge of Microsoft systems including: Word, Excel
Ability to troubleshoot and make quick decisions based on training
Experience in analyzing and reporting data
Experience in making accurate decisions with ambiguous content

106

Quality Assurance Specialist Resume Examples & Samples

An Associate degree with five or more years of related work experience; or
A Bachelor's degree with three or more years of related work experience; or a combination of education and experience that is comparable to the qualifications outlined above
Experience with Federal Acquisition Regulation (FAR) and other related requirements
Must be a U.S. citizen
Experience with relational databases and report generators is highly desired

107

Quality Assurance Specialist Resume Examples & Samples

Responsible for supporting and managing the overall quality assurance and control effort on this program
Participates in formal and informal reviews to determine program and information technology quality and in the development of software quality assurance plans
Examines and evaluates the SQA process and recommends enhancements and modifications
Develops information technology quality standards
Performs audits of the effectiveness of development processes and work products and recommends improvements as necessary
Must have 5-6 years of experience working with program management, systems development and IT quality control methods and tools Prototype development
B.S. or B.A. Degree
Must be capable of evaluating software and associated documentation
Must have at least 4 years of experience with quality management/quality assurance of programs with system development and implementation
Must have 2 years of experience in software testing and integration with a demonstrated knowledge of system and project life cycles and ISO 9000 and/or iCMM

108

Quality Assurance Specialist Resume Examples & Samples

Manage a portfolio of clients receiving Program Compliance services
Monitor, detect and enforce advertiser client(s) Special Terms and Conditions, CJ Code of Conduct, CJ Publisher Service Agreement, and CJ Network Quality standards
Advise on best practices for affiliate program quality
Develop and deliver regularly scheduled written/oral reports on both qualitative and quantitative aspects of program transactional quality, data trends, key challenges, and publisher rehabilitation efforts to advertiser clients, account managers and account directors
Manage client expectations
Own, coordinate, and enforce the process of “rehabilitation/deactivation” of questionable publishers
Craft and conduct the compliance portion of QBRs- Quarterly Business Review presentations
Time management/self-motivation
Must have strong analytical skills; proficient with spreadsheets and simple database functionality
Ability to speak, read, and write in one or more European and/or Asian language desired, but not required
Ability to effectively communicate and present in front of coworkers, clients, and executives
An understanding of online marketing and tracking methodologies is a plus
Familiarity with html, mobile app and software development is a plus

109

Quality Assurance Specialist Resume Examples & Samples

Batch Record Review for Rx and IMP batch disposition activities undertaken by the Welwyn Quality Unit including those relating to returns and temperature monitoring of chilled deliveries
Maintain and update SOPs and processes relevant to Quality Management Systems and other Welwyn Quality Unit Processes, including managing group e-mail accounts and tracking logs
Perform Quality Assurance activities (e.g. Audits, Recall support, Report writing, Discrepancy investigation, Change management, Technical support, document preparation and review) as required
Provide KPIs/metrics and trending data Welwyn Quality Unit processes including complaints, QMS, Vendor Assurance, Rx and IMP disposition to Line Management and Key Customer groups on a monthly basis
Undertake activities to assure Inspection Readiness of all relevant areas of responsibility (including identified affiliates, supported departments and third parties), and support Regulatory Inspections as and when they occur
Manage the reporting, logging and investigation of complaints received by the Welwyn Quality Unit; Liaise with Roche legal, drug safety, customer services, drug information departments and other Complaints Managers within the Roche organisation
Provide day to day support for the Rx Logistics, Customer Care, Medical and Clinical Operations departments regarding GMP relevant activities including

110

Quality Assurance Specialist Resume Examples & Samples

Oversee the HEE-I Quality Program. Work closely with HEE-I management to ensure the Quality Program supports ORAU, DOE, NRC and other applicable compliance requirements as well as customer specifications. Work closely with Associate Director and Group Managers to coordinate and integrate quality requirements into program activities
Ensure reviews of complex technical deliverables for quality aspects are completed, including verification of reported data, and ensure the level of quality meets customer requirements. Advise HEE-I Director on opportunities for more effective operational integration and streamlining of compliance requirements
Develop quality plans and perform general quality and data verification reviews for technical reports and other customer deliverables. Develop readiness reviews for the deployment of operational assets and lead or collaborate with others to conduct reviews
Serve as the owner of the HEE-I Quality Program Manual to address new or revised operations, changes in industry standard requirements, and ORAU/ORISE requirements. Ensure QPM requirements support ongoing, new, or revised operations
Serve as a key contact in HEE-I external audits and track status of external findings and observations. Ensure status is up to date in the HEE-I Quality Tracking System. Perform internal assessments and readiness reviews of HEE-I operations
Serve as the HEE liaison to the ORAU Office of Quality for ISO 9001 compliance, assessments and queries related to quality of operations and contractor assurance. Work closely with VPs and other HEE managers to effectively & efficiently integrate contractor assurance, compliance, quality initiatives, and business improvement efforts into HEE operations. Serve as the HEE liaison to ORAU Audit Services to facilitate conduct of internal audits and assessments

111

Quality Assurance Specialist Resume Examples & Samples

Lead development of test plans, test scripts and test data
Participate in functional and technical design reviews, perform integration/functional and system testing, and verify test results
Identify and document software defects
Participate with other project resources to resolve defects
Perform testing (data preparation and scripts execution)
Perform regression testing of software applications

112

Quality Assurance Specialist Resume Examples & Samples

Interpret and apply regulations to existing Hologic products to ensure compliance with these regulations in all OUS sites, dealers and distributors
Acts as a QA mentor on interpretation and application of regulations, laws, guidelines, standards and initiatives to Hologic Employees, dealers and distributors
Serves as a QA Interface to other departments, partners and Regulatory Bodies
Assists in the development and continuous improvement of the QMS
Manages and coordinates activities associated with aspects of the Quality Management System including
Bachelor or equivalent in a scientific discipline preferably biological sciences, life sciences or related discipline
Experience in a compliance role within medical device or pharmaceutical industries
Must have extensive experience of performing external audits as demonstrated by performing more than 6 Supplier / Distributor audits per year in a Lead Auditor Role. Preference given to ISO Certified Lead Auditors
Must have experience interfacing with competent authorities regarding audit activities and resolution of observations
Must have advanced knowledge of applicable regulations and standards related to medical devices internationally (ISO 13485, Medical Device Regulation, Anvisa, CFDA, etc.)
Strong working knowledge of Microsoft Applications including Excel
Ability to effectively train other individuals to Quality System procedures and programs
Ability to independently plan, execute, and/or problem solve moderate to complex situations
Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Must demonstrate initiative, balanced assertiveness working as a team player
Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
Ability to manage multiple projects
Regularly required to sit
Regularly required to use a computer keyboard, mouse, and monitor
Regularly required to talk and hear
Occasionally required to walk to meeting locations
Required to use close vision and adjust focus
Travel expected up to 30%

113

Quality Assurance Specialist Resume Examples & Samples

To provide consultative support on quality related issues to project teams
Participate in cross-functional teams as required
Ensuring all production steps have been performed and verified, that all limits and specifications have been met
QA support for qualification activities - review and approve equipment/utility qualification documentation from design to post execution
Review / approval of technology documentation
Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production
Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required
Participate in the internal audit programme as required
Maintain tracking system for project document review status
Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies
Co-ordinate and review change controls as required
Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition
Review of regulatory documentation
Assist in the creation and maintenance of up to date QA policies, SOP's and reports
Assist in the development of training curricula and records for the QA Operations Group
Perform and assist with additional duties as may be directed by the QA Ops Lead
B.Sc. degree in biology, chemistry, or other related technical degree
Min 4 years working experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role
Min 1 year experience in a lead role
Previous QC/QA and/or pharmaceutical experience in a GMP or GLP facility
An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment

114

Quality Assurance Specialist Resume Examples & Samples

Responsible for maintaining the Quality Manual
Maintain the supplier portal systems which include, but not limited to root cause corrective action
Support the maintenance of the process inspection aids and employee inspector stamps
Takes the lead during customer audits
Analyze process problem situations by reviewing facts and creating solutions. Appropriate solutions are selected based on operational and engineering guidelines, procedures, regulations, industry standards and past successes
Requires interaction with QA, QC, Production and Engineering in discussing and resolving complicated data and/or information with all levels of involved department personnel
Travel in the US and possibly overseas to customers will be required
Completes customer postal audits as required
Support the production of weekly / monthly reports as required
Reviews and analyzes corrective action reports in an effort to reduce and eliminate defects
Maintain a corrective action system
Monitors quality control / quality assurance activities and systems in production and maintains feedback contacts
Requires a high level of proficiency to apply significant job-related quality, engineering, manufacturing and processing experience
Ability to work with internal company and external customers
Computer literacy and personal communication skills are required

115

Quality Assurance Specialist Resume Examples & Samples

Actively participate in all phases of the Software Development Life Cycle (SDLC)
Analyze Requirements Traceability Matrix to verify requirements mappings are complete
Work closely with Program Managers, Requirements and Design Analysts, Engineers, Testers and Deployment Team to confirm work products are testable and certify deliverables comply with processes and procedures
Ensure all non-conformances are tracked to resolution prior to release
Collect and report on quantitative data related to software development activities
Assist the QA Manager in maintaining risk-driven Quality Management Plan (QMP) for end-to-end audits and reviews
Bachelor's degree from an accredited college or university required, equivalent experience will be considered in lieu of degree
5+ years of Software Quality experience required
Proficient with Rational Tools (RRC, RQM, CLM) required
Experience includes projects utilizing CMMI-DEV framework required
Comprehensive knowledge of SDLC methodology required
Possess strong written, verbal, analytical and organizational skills required
Proficient with Microsoft Office (Word, Visio, Project, Excel) required
Government Contractor experience preferred
Process Development experience preferred
Software Quality Audit experience preferred

116

Quality Assurance Specialist Resume Examples & Samples

Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition
Provide QA support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution
Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled
Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols)
Authoring, review and approval of QA-related procedures
Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA, and batch disposition
Review and approve Validation protocols as required. (Examples include cleaning, process, method validation)
Support the vendor quality management programme
Participate in regulatory inspections as required
Develop and report quality metrics
Provide quality oversight of calibration and preventative maintenance criticality assessments as required
Represents Quality Assurance to guide various projects and technical meetings, as needed
Min 4 years QA experience in a pharmaceutical manufacturing environment, preferably in a biopharmaceutical environment
Excellent communication & presentation skills are essential
Excellent time management organizational skills along with a proven ability to multi-task

117

Quality Assurance Specialist Resume Examples & Samples

Assist the Quality Assurance Manager with the implementation and continuous improvement of a Laboratory Quality System for the Influenza Division of CDC
Assist with document control and training related to CLIA, GLP, and GMP
Prepare, review and/or approve procedures
Conduct internal audits of laboratories, laboratory data, and computer systems
Assist with equipment qualification/validation procedures to include equipment calibration and preventive maintenance
Communicate progress orally and in writing (monthly) with technical monitor and others
Coordinate new staff quality orientation and training as well as ongoing quality training as needed
Quality assurance system development expertise with a strong background in the FDA regulatory environment for medical devices or pharmaceuticals or CLIA laboratory environment
Prior bench experience working in a CLIA, GLP or cGMP environment
Experience hosting audits by FDA

118

Quality Assurance Specialist Resume Examples & Samples

Reviews protocols for GLP, or applicable compliance, and SOP compliance/consistency
Performs critical phase inspections to ensure compliance
Performs facility inspections, critical phase inspections and data/report audits, which include monitoring for appropriate regulatory compliance, protocol and SOP compliance
Monitors budget through the course of the study and manages time accordingly
May provide assistance to other QA staff
Bachelor’s Degree in a biological science, chemistry or equivalent and a minimum of 1 year of applicable technical experience

119

Quality Assurance Specialist Resume Examples & Samples

A minimum of an Associate Degree is required; Technical or Science field is preferred
At least 4 years of experience in regulated industry is required; Medical Devices is preferred
2 or more years of experience in QA is preferred
ASQ certifications such as CQT and CQA are preferred
Bilingual (English/ Spanish) is required
Knowledge of QSR and ISO standards is required
Experience working with LIMS is preferred
Intermediate computer skills and use of software applications is required.Quality (Generalist)

120

Quality Assurance Specialist Resume Examples & Samples

Performs the more routine inspections and measurements, collecting and summarizing quality data, and maintaining records on the results of sampling procedures
Gathers information concerning the application of quality procedures, review of technical quality requirements, or the results of inspections and tests provide a basis for decisions and action by senior-level specialists
Performs audits of relatively simple work processes to insure that work is accomplished according to maintenance standards and specifications; and reviews test and calibration procedures
Provides information for an overall assessment of the timely and proper implementation of new or revised work processes, use of modified or new equipment, and other controlling procedures
Ensures quality processes are developed in conjunction with the user requirements
Reviews requirements, specifications and documentation to gain a thorough understanding of the programs and processes to be certified
Validates results, reports discrepancies and follows through to ensure that all issues are resolved
Must have a current TOP SECRET clearance which has been used in support of the U.S. Federal government within the last two years
IAT-I or higher certification
Experience using BMC Remedy in support of Service Desk Operations
ITIL Foundation in IT Service Management certified

121

Quality Assurance Specialist Resume Examples & Samples

Monitors and evaluates 70-100 Customer Service Reps on live phone interactions with bank customers
Monitors 3-5 calls per month for each Customer Service Rep
Monitors an average of 15- 20 calls per day
Communicates and gives feedback to Customer Service Reps on ways to improve their call quality, accuracy and productivity
Provides coaching for Supervisors as appropriate
Participates in weekly calibration sessions to ensure consistency in call monitoring
Attends one-on-one meetings with Lead QA Specialist
Work as a team with the other Quality Specialists to continuously rotate Customer Service Reps so that one does not always evaluate the same group
1-3 years previous call center experience
Demonstrated ability to operate independently and meet deadlines in time sensitive situations
Previous PC experience, specifically MS Word, MN Excel
Demonstrated knowledge of TCF products, services and procedures
Demonstrated ability to communicate effectively both verbally and in written form

122

Quality Assurance Specialist Resume Examples & Samples

Knowledge of jet aircraft and aircraft systems, including a strong emphasis on the electrical, avionic, and mechanical interfaces is required. An understanding of Federal Aviation Administration (FAA) operations and maintenance practices for certificated aircraft is desired
Ability to apply the principles of aerospace quality assurance, including the inspection process, control, product improvement, non-conformance reporting, corrective action, and auditing processes
Knowledge of the United States Air Force and United States Navy technical requirements, technical orders, and FAA regulations pertaining to maintenance, modifications, inspections, testing, and operation of public and civil aircraft and systems
Knowledge of aircraft and aircraft operations safety requirements and practices
Skill in planning, coordinating, and completing assigned projects
Skill in analyzing data and preparing reports

123

Quality Assurance Specialist Resume Examples & Samples

Monitor Product Support Agents calls and review emails for accuracy of information and call handling standards
Ensure that Product Support Agents are delivering a high level of customer service
Verify that agents are providing accurate solutions to customers
Record evaluations utilizing departmental quality monitoring forms
Deliver coaching feedback to agents on call and email performance
Provide Supervisors and the Manager with regular performance feedback on the agents
Assist with quarterly CSAT program by working with the Salesforce administrators on the delivery of the surveys and evaluating customer feedback received from the surveys
Prepares and analyzes quality reports for Management review
Participates in the design of quality monitoring forms and quality standards
Bachelor's degree or equivalent experience in related industry
Minimum of 2 years of experience performing Quality Assurance in a call center environment preferred
Experience developing and implementing QA programs highly preferred
Prior supervisory or leadership experience preferred
Proven ability to achieve and maintain departmental quality standards
Professional demeanor, dependable, and able to maintain confidential information
Strong written communication skills. Excellent grammar, spelling, and sentence construction
Must exhibit excellent leadership, communication, and interpersonal skills
Must have familiarity with Internet software and Windows operating systems
Demonstrated ability to rapidly gain product knowledge and effectively communicate it to agents
Proficient in Word, Excel and PowerPoint for presentations and reports required
Must be able to effectively communicate with agents, internal departments, clients and management
Demonstrated ability to train and develop new and existing support agents
Experience with RealPage products or with call center quality assurance practices preferred
Ability to work extended hours as needed
Primarily in-office support of clients and support agents, with some travel as needed
Able to work extended hours when required
Able to sit or stand for frequent periods in the same location with some opportunity to move about

124

Quality Assurance Specialist Resume Examples & Samples

Bachelor's Degree or equivalent required
Experience working within similar environment with proven successful results
Have excellent written and verbal communication skills, including facilitation skills, summarization skills and senior level comfort presenting to internal staff to help generate roadmap and presentations for staff to deliver to executive and legislative level clients
Have strong interpersonal skills, good situational awareness and emotional intelligence
Be a business-focused problem-solver, with an awareness of technology and data constructs
Understand, maintain, and work within the hierarchal organization reporting structure
Experience with IT Infrastructure Consulting project is a plus
Candidate must be analytical and effectively able to prioritize needs, requirements and other issues
Prospective candidates should have strong risk management skills, strong communication, and team work
Lead process improvement

125

Quality Assurance Specialist Resume Examples & Samples

Interaction with the Partners & influence change
Monitor and evaluate transactions / incidents of Open and closed transactions to ensure that quality standards are met
Monitoring of Voice and chat transactions
Certify new hire agents
Training Need Analysis
Case Reviews; Business Rules adherence Compliance
CSAT/DSAT Analysis
Feedback and coaching
Provide suggestions to ensure improvement in adherence to quality standards and improve overall team performance
Daily/Weekly/Monthly/Quarterly Quality performance reporting
Mandatory rotational shifts
Innovate based on Transaction Monitoring
Lead the partners to drive Customer results
Manage calibration calls with the objective to provide standardization across GEOs
Bachelor’s Degree or equivalent (10+2+3); Graduation in any stream
Exceptional customer service skills
Strong Team Player, capability to influence Team and manage Change
Minimum experience of 3 years in a Voice / chat based Tech / Customer Support Process as Quality Assurance Specialist or Higher or equivalent
Proficiency in English Language; Excellent Verbal & Written communication skills; Good Comprehension & Listening abilities
Proficiency with Computers (MS Office, especially Microsoft Excel – data analysis)
Good presentation Skills
Good knowledge about Windows operating system
Logical / Analytical skills; Problem solving skills; troubleshooting analysis; Eye for detail
Ability to coach, analyze Data for respective Teams, identify issues/ best practices
Ability to manage multiple tasks and proactively understanding dependencies / risks associated with any Project activity
Resilience & Flexibility
Drive & Persistence
Superior interpersonal skills - Ability to get along with diverse personalities, tactful, mature and flexible
Excellent analytical skills and strong decision making abilities
Six Sigma trained or Certified would be an Advantage

126

Quality Assurance Specialist Resume Examples & Samples

Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production
Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them
Bachelor's Degree must be from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline
Minimum of five (5) years of relevant experience
Experience in immune assay (ELISA, multiplex assays) development and validation
Experience in quality control and quality assurance related to immunology, virology and/or molecular biology procedures for reagent production and assay development and performance
Strong understanding of regulatory and GCLP requirements
Experience in high throughput testing and robotics
Experience in LIMS in use in immune monitoring laboratories

127

Quality Assurance Specialist Resume Examples & Samples

Improvement of selected supplier quality performance
Change point control, new model confirmation, and nonconformance resolution
Formally document supplier corrective action, and work efforts with supplier base
Bachelor’s degree in Engineering, Business Administration preferred or equivalent work-related experience in quality assurance and control systems, manufacturing processes, and parts compliance to engineering with strong manufacturing emphasis (CQA/CQE) desired
Working knowledge of various manufacturing process (i.e. stamping,

128

Quality Assurance Specialist Resume Examples & Samples

Understanding of sanitation and pest control practices
Strong computer, document management skills and attention to details
Dexterity required for handling and performing tests in an accurate manner. Ability to record data as needed
Solid understanding of a production / manufacturing environment
Strong auditing / assessment skills
Proficiency in computer programs / software such as Microsoft Word, Outlook, Excel, Access, Power Point, SAP (Recipe Management), Net Weight and QA Trends

129

Quality Assurance Specialist Resume Examples & Samples

Perform routine inspections and measurements for incoming and in-process production items
Perform final inspection of equipment and materials prior to shipment to customer
Interface directly with suppliers to resolve incoming material/equipment defects
Ensure all required production equipment is calibrated at the proper calibration intervals and adequate records are maintained and filed properly
Review and process supplier-provided and in-house generated test documentation
Assist with labelling and tracking of serialized components and assemblies
Review quality processes and make suggestions for continual improvements
Excellent communications skills
Ability to be assertive in a professional manner
Must be very detail oriented and highly organized
Typically requires a bachelor’s degree or equivalent and zero to two years related experience
US citizenship is required
Experience with a production related Quality Management System

130

Quality Assurance Specialist Resume Examples & Samples

Works closely with team members to identify opportunities for improving efficiencies related to corporate operational processes and compliance
Reviews loan boarding to verify correct loan set up in corporate loan system
Conducts necessary group and individual training related to improving corporate operational processes and compliance
At the direction of a supervisor, works on special projects focused on improving corporate operational processes and departmental reporting.Attends Credit Risk meetings and completes meeting minutes
Assists with compiling and maintenance of monthly reports and quarterly Board Reports
Department Compliance Liaison
Commercial Real Estate and C&I loan documentation is preferred
Corporate loan participations and syndication
Corporate credit agreements, loan closing process and procedures, lending policies, compliance and lending regulations
Advanced concepts, practices and procedures of commercial loan documentation and processing
Principles of banking and finance
Corporate markets and products
Multi-state real estate, closing, and title practices
Federal and State lending laws
Preparing records and reports
Advanced Word and ExcelOperating standard office equipment and using required software applications
Associate’s Degree and a minimum of three (3)-five (5) years experience in operations

131

Quality Assurance Specialist Resume Examples & Samples

Ensuring that the validation / qualification activity are executed in accordance with the GxP requirements
Participation and supervising of validation / qualification work
Reviewing, opinions and / or approving the validation of documents and other documents of the quality system, including risk analysis, deviations and changes in the validation / qualification,
Participation in the validation project teams
Initiating, evaluation, monitoring, implementation and supervision of corrective actions in the validation / qualification activity due to occurrence of non-compliance with the established quality system requirements, and supervision in the process of determining and implementing preventive action
Conducting internal training in terms of validation / qualification
Participation in the timely preparation of the Annual Product Review
Tracking, interpretation, implementation and compliance with the GxP requirements, global requirements included in the Quality Manual and the Global Operating Procedures related to the validation / qualification
At least 2 years’ experience in validation / qualification activities of production equipment
Proven track record in providing business related support for internal stakeholders in terms in quality assurance aspects
Ability to lead corrective actions, manage deviation processes and very good knowledge of quality tools eg. change controls management, deviations, risk analysis
High level of analytical skills
Strong interpersonal skills and agility to collaborate in cross functional teams

132

Quality Assurance Specialist Resume Examples & Samples

Participate in all aspects of the QA job function, e.g. processing of Product Improvement Reports (PIRs), Quarantine, Recovery, Customer Recovery and Advisories (QRRs), change notifications, customer surveys, quality certificates, internal audits, SalesLogix tickets, generation of supplier and team metrics, etc
Process the download and distribution of Product Improvement Reports (PIRs) daily. Identify those PIRs requiring escalation. Work with customer service to fully document the customer’s allegation and facilitate the return of product to be evaluated. Coordinate investigations with suppliers, and communicate root cause and corrective actions to customers
Coordinate investigation of quality issues with customers and suppliers. Review, approve and communicate root cause and corrective action to stakeholders
Facilitate the quarantine, recovery and disposition of products including those that may be sensitive in nature for regulatory or legal reasons
Collect and analyze quality data, run Oracle queries, and prepare and distribute quality reports
Respond to customer surveys and Requests for Proposal, (RFPs) in a timely manner
Create and revise QA procedures and work instructions
Participate in internal audits of the Quality Management System
Participate in continuous improvement of core processes, using Practical Process Improvement (PPI)
Present QA functions and provide training as required to departments outside of QA
Execute projects and complete other duties as assigned
Organized and works with a sense of urgency
Flexible team player
Experienced in dealing with customers and suppliers
Skilled problem solver with a results orientation
Strong computer and analytical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Data Warehouse tools
Experienced in a continuous improvement methodology and related analytical tools, e.g. Six Sigma, PPI, Lean, Minitab, Corrective and Preventive Action (CAPA), run charts, flow charting, Pareto charts, pivot tables etc
Minimum two years experience working in an ISO (13485 preferred) and/or FDA current Good Manufacturing Practices (cGMP) environment
Experienced internal or external auditor, lead auditor experience preferred
Experience working with a quality information management system, Master Control preferred
Bachelors Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics
Ability to travel and work in a laboratory, warehouse or manufacturing environment; less than 15% of the time
Experienced in a continuous improvement methodology and related analysis tools, e.g. Six Sigma, PPI, Lean, Minitab, Corrective and Preventive Action (CAPA), run charts, flow charting, Pareto charts, pivot tables etc

133

Quality Assurance Specialist Resume Examples & Samples

Become well versed in all aspects of the QA job function, e.g. processing of Product Improvement Reports (PIRs), Quarantine, Recovery, Customer Recovery and Advisories (QRRs), change notifications, customer surveys, quality certificates, internal audits, SalesLogix tickets, generation of supplier and team metrics, etc
Collect and analyze quality data, run Oracle queries, and prepare and distribute the quality reports
Respond to customer surveys and Requests for Proposal (RFPs) in a timely manner
Visit suppliers and warehouses, as required, to bring attention to and resolve quality related issues
Train and provide assistance to less experienced members of the QA team
Drive continuous improvement of core processes, using Practical Process Improvement (PPI)
Present QA functions and provide training as required to functions outside of QA
3+ years of experience working in a regulatory, quality assurance/control, laboratory, or operations environment
Experience in dealing with customers and suppliers and supplier management processes
Experience working in an ISO 13485 and/or FDA current Good Manufacturing Practices (cGMP) environment
Experienced internal and external auditor and auditor experience
Experience working with or administering a quality information management system and Master Control

134

Quality Assurance Specialist Resume Examples & Samples

Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement and Innovation (The Four I’s)
Ensure adequate document control for manufacturing and packaging instructions and cGMP Standard Operating Procedures
Assist with deviation identification and documentation
Perform Packaging In-Process checks
Provide assistance and guidance on quality issues for Operations. Escalate necessary issues to Quality Assurance Representative and/or Manager
Assist with periodic self-inspections to assure cGMP compliance
Thoroughly examine Label Specifications, Master Label Proofs, Randomizations, and

135

Quality Assurance Specialist Resume Examples & Samples

Work with the development and application teams to define process and strategy associated with testing automation
Evaluate and recommend testing solutions that would meet both functional and technical requirements
Implement and develop automated test practices for both on premise and hosted applications
Design and create test scripts using approved toolsets to address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability in preparation for implementation
Identify, analyze, and document testing results with program function, output, user interface, user experience, or content. Generate testing metrics. Provide summary of testing results and recommended actions
Maintain an up-to-date library of testing scripts for various applications
Plan and coordinate testing schedules or strategies in accordance with software release scope / delivery dates
Be familiar and able to train development team on Test Driven Design methodologies and Unit Testing methodologies
6 to 8 years of experience working in an Information Technology environment
Minimum of 2 to 3 years of experience working with Software Quality Assurance
The ability to work independently and collaboratively
Superior interpersonal and communication skills necessary to effectively interact and communicate with other team members, managers and clients
Proven experience developing automated test scripts utilized various testing tools for both web and windows applications, hosted externally or on premise
Ability to create complex testing scripts encompassing business logics, emulating users’ inputs to validate business processes and designed functionalities
Knowledge of multilayered software architecture and how to structure testing for each layer
Solid understanding of various Software Development methodologies, Test Driven Design methodologies and Unit Testing methodologies
Experience with source control systems and configuration management
Experience with Agile development methodology preferable
Ability to establish priorities, to meet deadlines, to multi-task on various projects and requests, and to still be able to focus on details in a fast-paced demanding work environment
Experience with PeopleSoft 9.2 and Oracle E-Business Suite 12.1 is an asset
Technical Skills -Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities and takes ownership of tasks at hand
Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals
Completes tasks on time or notifies appropriate person with an alternate plan
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work
Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests
Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed

136

Quality Assurance Specialist Resume Examples & Samples

Responsible for completing quality audits on transactions with detail research and investigation if the transaction has been processed according to standard procedures and policies
Uses the organization's resources to enhance customer satisfaction
Ensures that data and information are sufficiently accurate and reliable
Participates in design of quality scorecard formats and quality standards
Performs transaction audits and provides trend data to site management team
Actively participates in internal and external calibration sessions
Provides feedback

137

Quality Assurance Specialist Resume Examples & Samples

To work with and support the operations management for ensuring excellence in the operations of GDC by mapping and driving continuous improvement in QA processes of project delivery. To communicate, implement and control the Company QA system across GDC
Plans the communication, implementation & satisfactory operation of the Quality Management System in close coordination with the management team and in line with the ISO 9001 requirements
Act as the management representative for the QA system
Liaises with AECOM internal clients, Regional Leaders of various business lines, functional areas, employees and third-party service providers
Promotes the training and education of employees in quality oriented subjects
Reviews the Project Quality Plans
Ensures registration of Agencies/Sub Contractors
Reviews documents transmitted to clients & external agencies
Schedules project and functional audits
Prepares agenda and documents for Management Review & Quality Group Meetings
Analyses the quality performance of the company by reviewing quality records and reports to the Management Review Group
Records of review include but not be limited to
Internal quality audit reports
Corrective & preventive action plan reports
Customer survey & feedback reports
Agencies/subcontractors performance reports
Updates, communicates and controls the quality system procedures and quality manual
Manages internal audits as well as external quality audits (to be conducted by the Certified Bodies)
Support Project Managers with QA system and procedures and ensure that project QA system meets the client requirements
Graduates with Bachelor’s degree in Engineering discipline preferred
Professional registration/certification to QA processes is preferred (such as lead auditor, six sigma)

138

Quality Assurance Specialist Resume Examples & Samples

Monitor field, product characterization, and/or safety studies for quality and compliance as required by the Good Laboratory Practices regulations (40 CFR Part 160), Standard Operations Procedures (SOPs) and corporate policies
Assess compliance/quality systems of internal and contract research facilities, recommend corrective/preventative actions; initiate/contribute to continuous improvement quality initiatives
Negotiate solutions to potential compliance matters; foster interactions between functional groups for overall quality/compliance improvement; act as a resource to Regulatory personnel with respect to understanding of GLP regulations; develop and deliver training courses; participate with the Regulatory organization's cross-functional new product teams
Prepare for and host regulatory agency inspections
BS in a biological science, chemical or life science related field of study
3+ years experience in a biotech/pharma/ag research role combined with 1+ years experience in a research quality role (e.g. GxP/ISO QA/QC)
Excellent communication skills (written and oral)
Process-oriented with demonstrated attention to detail
Enjoy working in a fast paced environment and interacting with scientists from diverse disciplines
Experience in the biotechnology industry
QA experience in a GLP regulated environment
Demonstrated leadership involving process improvement projects

139

Quality Assurance Specialist Resume Examples & Samples

Assists QAO in monitoring program adherence to the project’s Statement of Work (SOW), this includes reviewing artifacts and ensuring the timely completion of the independent quality reviews and audits
Based upon QA reviews, analyzes evidence and issues reports of discrepancies and deficiencies, and assist in the implementation of corrective action follow-up to ensure expected outcomes are achieved
Respond to requests by department managers to conduct ad hoc quality reviews and assist in direct service delivery
Assist with quality assurance planning activities, including development of Quality Assurance workplans and schedules
Develop and work with Training, Development, and Outreach (TDO) departments to deliver training when specific trends are identified during quality audits
Identify and implement best practices performed under terms of Contract and ensure consistent, standard execution of operational activities
Identify potential process improvements and assist with improvement initiatives when appropriate
Provide consulting services to clients in specific domain of expertise
Assist with gathering results from QA program activities and development of QA reports and metrics to meet internal and external reporting requirements
Workload permitting, QA Specialist may be tasked with providing QA support to other departments within Business Unit
Process compliance, auditing, quality assurance, testing and control
Call center monitoring
Excellent organizational and time management skills, ability to multi-task
Possess strong customer service orientation
Ability to effectively collaborate with team members to achieve project goals
Excellent verbal communication skills and ability to communicate at all levels
Possess effective business writing skills
Proficient in use of Microsoft Office programs (intermediate - advance level)
Associates degree required, or equivalent experience, Bachelor degree in Business Administration or related field preferred
Knowledge of ISO 9001:2008, Lean Six Sigma is highly desired

140

Quality Assurance Specialist Resume Examples & Samples

Works to continually monitor adherence to established quality assurance performance standards
Assists the director in implementing the program's Quality Assurance and Performance Improvement Plan, provides technical assistance to staff in the execution of the plan
Assures the provision of targeted training designed to equip all staff with the necessary tool to achieve improved performance
Collects, analyzes, tracks and trends establishes quality assurance and performance improvement measures
Works with the Director of Quality Assurance and the Director of Social Work to assure a timely and thorough response to any identified areas of need, including implementation of corrective action when indicated, additional training, and identifying needed resources to achieve quality performance goals and benchmarks
Assists Directors and Managers in coordinating activities related to maintaining compliance with all regulatory agencies
Fosters an environment of compliance, integrity, and continuous improvement through education and communication
Bachelor's degree in a health related field
Two or more years of clinical and quality improvement experience in partial, acute, and/or residential psychiatric or outpatient mental health services
Risk Management experience is a plus
Must possess a thorough understanding of the performance improvement process, including application of concepts and the ability to impart that knowledge to others through effective teaching techniques, and assess systems for performance improvement through monitoring and evaluating
Must be PC literate with some ability to utilize spreadsheet and graphic programs to produce bar graphs and charts
Knowledge of regulatory standards as related to therapeutic foster care services preferred

141

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance during the migration and transition phase, and disaster recovery requirements built into the solutions
Providing independent assessments of the health of the database(s) used by the customer as well as providing feedback on where the customer is exceeding or under resourced in asset areas
Conduct quality assurance reviews
Bachelor’s Degree in information technology, information systems, computer science, or a related field or equivalency
10 plus years of related work experience
Microsoft office suite capabilities

142

Quality Assurance Specialist Resume Examples & Samples

Performing sampling and analysis of materials
Evaluating the quality of products produced throughout the process
Performing process audits
Analysis trends and/or solutions to develop recommendations for a more efficient approach; and
Performing first article inspections in a manufacturing environment

143

Quality Assurance Specialist Resume Examples & Samples

May support quality investigations/deviations
Interface directly with contract manufacturers and alliance partners to resolve quality related issues with minimal supervision
Maintain electronic records in Trackwise, Oracle Enterprise Business Suite (EBS), Electronic Batch Review Systems, Vevva Vault, etc., and paper archives as needed
2+ years of relevant experience in a GMP environment related field and a BS
3+ years of relevant experience and an AA degree
Working knowledge of Quality Systems and cGMP standards
An accountable team player who is detail and quality oriented with an understanding of quality assurance principles, systems, and procedures

144

Quality Assurance Specialist Resume Examples & Samples

Ensure compliance with cGMP regulations, ICH guidelines, Corporate and local SOPs and specifications
As QA on the floor/person in plant (PIP) perform line clearance, real time documentation reviews, spot audits, and Quality guidance on Manufacturing concerns
Review executed paper production drug substance batch records and support documentation
Review raw material inspections and release raw materials. May be backup for performing raw material inspections
Initiate deviations and change control as needed. Assist/perform deviation investigations, including root cause analysis using common RCA/FMEA tools/methodology
Recognize/Participate/Lead change for Quality System/Process improvement
Perform other duties as assigned by Management
Bachelors’s degree in a scientific discipline
3+ years Manufacturing experience in biopharma/pharma
5+ years of Quality Assurance experience in biopharma/pharma,

145

Quality Assurance Specialist Resume Examples & Samples

Ensures implementation and compliance procedures and instructions related to the operation of quality systems requirements
Consumer Complaints Management
Analyzing root causes of non-compliance
Ensures new products implementation according to plant standards
Implementation of internal audits according to the schedule
Implementation of corrective and preventive action
Conducting trainings for operators
Cooperation with the production department and other departments
First Plant contact for external institution in quality aspects
At least 1-2 years of professional experience in an independent position
Experience in a food industry (obligatory requirement) at the positions such as: Quality
System Specialist, Laboratory/ISO Coordinator, Auditor
Practical knowledge of HACCP, ISO system ( ISO auditor certificate welcome)
Experience in leading projects
Good, practical knowledge of English which enables to communicate
Excellent interpersonal skills, ability to work independently
Practical knowledge of tools supporting project management: MS Excel, MS Project, MS Visio, SAP
Fluent Polish and English

146

Quality Assurance Specialist Resume Examples & Samples

Bachelors Degree in a technical, scientific area
Five (5) years of experience in a regulated technical, scientific or business field where documentation practices and attention to detail are job requirements
Two years in addition to the experience required above of progressive quality documentation or closely related experience may be substituted for the education listed above
Good documentation practices
Lotus Notes applications
MS Office software
Communicate effectively in writing and verbally
Indentify and use internal resources to complete assignments
Accurate, efficient data processing
Time management and a sense of urgency when appropriate
Communicating with persons in multiple disciplines and varying levels of experience

147

Quality Assurance Specialist Resume Examples & Samples

Basic knowledge in overall production, quality assurance, commercialization at supply ends
Familiarity with HACCP, GMP, quality system
Preferably 3 years’ experience in a technical competence area
Quality management and experience of leading continuous improvement in the fields of Quality
Experience in the application of World Class Manufacturing techniques and standards
Experience of supplier management with manufacturing process

148

Quality Assurance Specialist Resume Examples & Samples

Analyze internal audit (Quality Control) performance reports
Research and evaluate Quality Control and Quality Assurance procedures and auditing system for continuous process improvement
Analyze needs and performance gaps and build resolution measurements and processes
Develop and maintain training material and training programs for various methods of delivery, including: face-to-face, online (eLearning), self paced, structured programs)
Act as an internal reviewer and editor for department documents and training material
Assess training effectiveness
Create and maintain project and action plans
Conduct research regarding mortgage lending quality control best practices, regulatory requirements, etc
Perform internal Quality Control audits, including on-site branch audits as needed
Deliver training in some cases

149

Quality Assurance Specialist Resume Examples & Samples

Installation, configuration, and troubleshooting of enterprise server and client applications on Microsoft Windows, Linux and Mac in virtual environment
Working experience in software testing for enterprise system consisting of distributed server components, databse server clients, WebUI, and supported HW devices
Working experience in developing test automation scripts for functional testing
Working experience in agile environment for fast-paced software development and testing release cycle
Strong trouble-shooting skills to identify root cause and narrow down issues
Written and verbal communications demonstrated through the creation of test plans, defect documentation, and result report
Experience in software testing with large scale network infrastructures including distributed servers, clusters, load balancers, and network protocols, such as TCP/UDP, DNS, AD, LDAP, SMTP, SSL/TLS, etc

150

Quality Assurance Specialist Resume Examples & Samples

Bachelor’s degree in Chemical Engineering, Food Science, Biology, Microbiology, Chemistry or related sciences
Current knowledge of food safety within FSSC 22000 and customer/regulatory requirements
Demonstrated proficiency in effectively managing relationships
Familiarity with the CWM process and experience working in a plant environment would be a plus
LSS Orange or Green Belt certification desired
Ability to recommend solutions to resolve non-conformancies

151

Quality Assurance Specialist Resume Examples & Samples

Act as champion of accurate root cause analysis for customer concerns
Bachelor of Science Degree (i.e. Engineering, Chemistry, Microbiology, Quality etc.)
Three to five years’ experience working in QA with food or pharmaceutical ingredients or products
Excellent oral, written, and communication skills. Provide examples of formal written communication
Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point, Visio, flowcharting software and experience with Electronic Documentation Systems a plus
Ability to understand customer requirements and implement meaningful corrective actions to enhance the ease of doing business with Ingredion
Ability to evaluate and prioritize position responsibilities to meet established timelines
LSS Certification, a plus
Ability to support the QA and Purchasing team
Ability to work with others to implement system changes

152

Quality Assurance Specialist Resume Examples & Samples

Strong problem-solving and conflict-resolution skills
Ability to handle multiple tasks while adapting to changing priorities
Ability to work with minimum supervision
Ability to think out of the box and meet deadlines
Experience with Agile and iterative project life cycles preferred

153

Quality Assurance Specialist Resume Examples & Samples

Implementing, interpreting and maintenance of the Test and Evaluation Division Quality Management System (QMS) and document control. Including planning and improvement from product process design, manufacturer, verification/ validation and audit
Developing documentation components of the quality system including identification of support interpreting technical data, data analysis and report writing to develop regulations, policies or other guidance material
Applying national and international standards appropriate for TSA Test and Evaluation programs
Implementing training program for the Operations Support Division covering training conduct, arranging training opportunities from qualified sources, tracking of test resources training accomplishment and records keeping. Conducting needs analysis, develop and/or approve curricula and materials to determine training program effectiveness
Designing, performing and document internal audits in accordance with ISO 9001 requirements as implemented by the Transportation Security Administration Test and Evaluation program. Distinguishing between types of quality audits including: product, process, management system, registration and compliance audits. Providing expert internal audits, conduct corrective action tracking and performance metric development for TSA’s test and evaluation program
Apply statistical quality control plans in methods as applied to test and evaluation programs. Applying descriptive statistics, defining and distinguishing between probability distributions. Utilizing statistical decision making techniques such as hypothesis testing and implement statistical process control
Maintain TSA System Integration Facility, International Organization for Standardization (ISO) certification. Coordinate International Organization for Standardization registrar to manage implementation of program modifications
Implementing elements of test-related, data quality management systems
Planning and interpreting technical data systems
Facilitating quality assurance improvement of functional programs
Completed formal training related to quality system management, quality auditing, and/or ISO 9001 quality management systems
Designing and documenting quality assurance programs/process of internal and external audits

154

Quality Assurance Specialist Resume Examples & Samples

Participates in the internal auditing process, including audit planning, conducting audits, preparing audit reports, and follow up on non-conformances as directed by the QA/QC Managers
As directed, works with the QA/QC Managers in establishing satisfactory quality plans and programs. Assists in retrieving, assembling, and organizing for the QA/QC Managers contract documents under development to ensure that all plans and procedures are available to determine if appropriate quality provisions are being incorporated into the projects
Under the supervision of the QA/QC Managers, assists in reviewing the quality assurance and quality control (QA/QC) plans of contractors, consultants, and WMATA. Assists the QA/QC Managers in conducting regular and ad-hoc audits of the contractors’ QA/QC programs
Assists in providing oversight of independent QA/QC inspection and testing provided by consultants and contractors. Provides administrative assistance in issuing Issues Requiring Resolution (IRR), Corrective Action Requests (CARs), and Supplier Correction Action Requests (SCARs) to address quality issues from construction contractors/subcontractors and tracks progress of IRRs, CARS, and, SCARs
Assists the QA/QC Managers in the systematic review of quality assurance surveillance findings; assists in trend analyses to identify areas of recurring findings; and proposes to the QA/QC Managers the development and implementation of corrective action plans to improve the Rail Project Quality Program
Assists the QA/QC Managers in preparing coordinated Rail Project responses to audit and project management oversight reports received from FTA, and/or other Federal, State and local agencies
Assists the QA/QC Managers in communicating and interacting with internal and external business contacts, including but not limited to other members of the Program Team and other Airports Authority employees (such as executives, managers, supervisors, and professionals)
Reports any discovered deviations and non-compliances that may be observed during Project execution
Assists with quality training such as facilitating logistics, preparing handouts, and any requisite follow-up
Performs administrative duties required by the QA/QC Managers, such as updating various registers, maintaining quality records, documentation, and working within various document control software platforms
Coordinates with site quality teams to ensure commonality of approach
Facilitates the completion of project quality documentation as required
Assist in the preparation of periodic reports summarizing progress of quality activities
Performs other quality assurance responsibilities associated with this position as may be appropriate
Seven (7) years of professional quality assurance/control experience on large/complex transportation systems. Three years of rail and audit experience preferred
Strong written and verbal communication, organizational, and interpersonal skills are a plus
Proficiency in utilizing PC software packages to include a variety of document control software platforms typically associated with construction projects is desired

155

Quality Assurance Specialist Resume Examples & Samples

Appropriate qualifications; e.g. degree level, membership of the CQI, approved quality auditor (e.g. IRCA), or equivalent qualifications and/or experience
Good communication skills, including clear and concise report writing
Knowledge of a European language or languages would be desirable; e.g. from German, Spanish, French, Swedish, Dutch, Portuguese, Italian, Russian, Greek, or Czech
Good understanding of Microsoft tools, knowledge of SharePoint (Hub) etc

156

Quality Assurance Specialist Resume Examples & Samples

Evaluate phone, email and chat interactions daily using several quality coaching tools
Assess performance of all employees who interact with customers
Identify and communicate service trends and training needs
Train new hires in QA standards and process
Act as content expert liaison for one or more partners
Participate in weekly calibration sessions
Create and deliver coaching sessions for individual agents as directed
Ensure adherence to company policies and procedures
Maintain accurate, detailed logs and provide reporting of quality coaching results to QA Supervisor, home office Supervisors, and outsource partners bi-monthly
Act as system administrator of quality coaching tools; Interact with quality monitoring vendors and attend related training to ensure the optimal use of quality coaching tools and systems
Assist with floor management needs, including handling escalated customers, overflow call/email volume, and CS team leadership as directed
Maintain current understanding of policies and procedures, website changes, new products and processes of company and customer service center
Is widely trusted by others
Completes work according to standards as determined by supervisor/manager
Adheres to work schedule as set by the needs of the contact center
Support additional duties as necessary

157

Quality Assurance Specialist Resume Examples & Samples

High School Education or equivalent
Previous PC experience, specifically MS Word, MS Excel
Demonstrated knowledge of TCF products, services, and procedures

158

Quality Assurance Specialist Resume Examples & Samples

Identifies issues and trends, analyzes data, proposes solutions, keeps statistics and reports to management for performance improvement opportunities. Provides input to identify quality and process improvement opportunities within all Divisional Service Lines
Reviews all Service Line credentialing Processes and works collaboratively with the credentialing team to develop Quality Assurance metrics and benchmarks
Investigates and responds to Quality Assurance inquiries, problems, questions or requests in timely and professional manner to ensure resolution and positive Quality Assurance
Documents appropriate information on computer system based upon department documentation standards. Handles critical workloads and/or department special projects as assigned
Processes assigned reports
Demonstrates ongoing competency skills. Demonstrates above level problem solving skills and decision-making abilities. Demonstrates knowledge of various regulatory agencies

159

Quality Assurance Specialist Resume Examples & Samples

Participate in monitoring calls with all sales representatives, evaluating the quality of each call based on the Quality guidelines and standards
Complete regularly scheduled audits and prepare weekly audit summary reports to the Manager
Provides functional guidance, training and assistance to the customer service staff
Communicates appropriate options for resolution in a timely manner
Assists management to improve efficiency and effectiveness
Commit to continuous process improvement in order to keep our Quality Assurance standards and practices meeting the needs of our customers and the company
Performs other duties assigned by Manager

160

Quality Assurance Specialist Resume Examples & Samples

Ensure the expected quality and accuracy of the software deliverables
Prepare and maintain the test cases for automated testing tools
Write and maintain the test scripts to validate each software component and demonstrate the business condition under test and the expected results (HP Quick Test Professional)
Establish a test strategy accordingly with the TCoE best practices
Participate in the development iteration and acquire competencies on the developed functionalities
Provide feedback to the development team and ensure the work is carried out in accordance with the quality requirements and the agreed planning
Participate actively in the market and end-user acceptance phases
Provide estimates and feedback to the Software Development Manager for project scheduling purposes
Propose improvements
Significant experience (3+ years) of testing in complex environments and large companies
Significant experience with writing and executing functional test cases
Experience with analyzing and documenting complex technical issues
Experience with off-site test centers is a plus
Significant experience (3+) of scrum testing
Knowledge of development and testing methodologies
Experience with HP tools (ALM, QTP, Performance Center, etc.) would be considered a plus
Experience on other ART tool
Significant experience (5-10 years) of scrum testing

161

Quality Assurance Specialist Resume Examples & Samples

Must have good client relations and communication skills
Must be able to work independently with little oversight
Typically requires bachelor’s degree or equivalent, and 5-7 years of related experience

162

Quality Assurance Specialist Resume Examples & Samples

Receives customer (clients, providers, facilities, etc.) grievances and grievances and documents each contact in the system
Researches and resolves complaints in collaboration with the Quality Assurance Supervisor and General Manager
Provides grammatically correct, well-written, and appropriate responses to grievances
Uses critical thinking and knowledge of NEMT to develop action plans in conjunction with Quality Assurance Supervisor
Ensures all customers receive accurate service information. Maintains appropriate correspondence with complainant from receipt of complaint to resolution
Produces complaint reports, summaries, and program reports/letters
Monitors and scores customer service representative calls
Provides superior customer service to clients, members, providers, facilities etc
Manages information regarding specific eligibility requirements for all programs within the Medical Transportation Program
Performs other related duties as required
3 years minimum in customer service, quality assurances, or investigative environment
Must type a minimum of 45 words/minute General computer and software experience (word processing, data base software and spreadsheet.)
Critical thinking and problem resolution skills
Superior customer service skills
Must be able to work independently in a fast-paced/multi-tasked environment and understand the concept of customer service and success

163

Quality Assurance Specialist Resume Examples & Samples

Education equivalent to graduation from high school with some college, plus the equivalent in Quality Assurance related work experience demonstrating excellent analytical and reporting skills as well as call center customer service & telephone phone skills
Minimum of three years of work experience, preferably in a quality assurance, customer service plus analytical reporting environment, or the equivalent in related work experience
Ability to analyze and resolve complex problems and exceptions in order to complete final resolution processes
Demonstrates general knowledge of quality standards and systems

164

Quality Assurance Specialist Resume Examples & Samples

Support cGMP manufacturing material requirements, responsible for assuring acceptable materials released per material specifications
Lead the materials release team and maintain daily schedule
QA review and release of cGMP materials and components
Communicate and coordinate effectively with other departments
Write and maintain cGMP procedures
Write and review material specifications
Collaborate with QC to assure required testing is performed
Collaborate with QA to assure that materials are appropriately qualified and tested per material specifications
Perform investigations for nonconforming materials
Maintain inspection ready procedures and participate in audits and inspections
Maintain appropriate labeling of incoming materials
Work proactively on a daily basis to ensure schedules are maintained and material is readily available
Manage conditionally released material disposition
Assist with Materials release weekly and monthly metric reporting
Identify continuous improvement efforts, including cost/expense control while maintaining GMP compliance
Build quality into all aspect of the material release process by maintaining compliance to all quality requirements
Evaluate Validation documentation and procedures to increase efficiency while maintaining regulatory requirements
At least five years experience in a Quality Assurance role involving cGMP materials, preferably in a pharmaceutical or medical device industry
Working knowledge of MRP principles and materials management is a must
Computer software knowledge (Microsoft Office)
High degree of initiative with demonstrated ability to work independently and meet timelines
Work collaboratively, act decisively and have passion for internal customers

165

Quality Assurance Specialist Resume Examples & Samples

Provide front-line support to end users before, during, and after the SAP and business process rollout which can include expert-led training, ‘how to’ support and escalation of issues
Responsible for data quality review including, data quality reports, unapplied payment monitoring, unbilled monitoring (particularly service) and incompletion log monitoring
Work closely with the Center of Excellence and Support Desk in developing knowledge based learning and issue resolution databases
Act as an extended member of the Center of Excellence and help facilitate the implementation of SAP releases
Provide Change & Readiness team with information, updates and feedback on key issues and concerns expressed by program participants; make recommendations regarding process improvement
Maintain, update and audit all applicable central data elements for support area
Advocate and support change initiatives within the Area
Maintain a professional image
Perform other duties as may be assigned (i.e. CRR, Lockbox, etc)
Understanding of AmeriGas business direction , organization, and culture
Aptitude for computer systems, including experience in Windows™ applications
Comfortable with navigating and working with ambiguity
Ability to take direction well and work independently
Aptitude and enthusiasm for learning and teaching others
Ability to work both independently and within a team
Ability to adapt positively to a changing environment and shifting priorities
Adaptability and flexibility; quickly learns and adjusts to changes in circumstances
Ability to influence others to take actions and achieve objectives
Demonstrated ability to make sound judgments and decisions
Minimum High School diploma required
Experienced CRR or 5+ years in a general business environment
Microsoft Office (e.g., Word, Excel, PowerPoint) should be at intermediate level
SAP knowledge essential

166

Quality Assurance Specialist Resume Examples & Samples

Will support and encourage the implementation and continuous improvement of the Greif Production System
May design, institute, and document safety and environmental programs, including Food Safety assurance
Advises plant management on all quality related issues (may include environmental and safety related issues)
Measures customer satisfaction and takes corrective action as appropriate. Implements “just in time” techniques to ensure quality levels remain high and consistent
Performs periodic testing and documents results for certification and compliance purposes
Develops reports as required by management
Coordinates activities with other departments and outside functions
May be responsible to ensure that the Greif Production System is being effectively deployed throughout the plant, initiate, plan and assist in the execution of improvement activities
May be required to monitor adherence to established safety standards. Recommends and implements changes as needed
May assist in training on Lean Manufacturing techniques
4+ years experience in quality assurance/control in a production setting
Strong project management skills

167

Quality Assurance Specialist Resume Examples & Samples

Review and rate phone call recordings and email responses of Customer Experience representatives using the prescribed quality guidelines
Provide clear, detailed and actionable constructive feedback to or Customer Experience representative and recommendations to the Supervisor in-charge
Facilitate calibration meetings to ensure consistent understanding of quality guidelines and expected behaviors
Recommend ways to improve processes, call flows, scripts and guidelines based on actual call and email reviews and observations
Document quality assessments and feedback
Generate and manage trending quality scores and relevant data while providing reports to stakeholders as prescribed by TQA Management
Bachelor's degree in either Education, Communications, Business or a related discipline; or equivalent combination of education and experience that is required for the specific job level (Minimum of 1 year, 2 years and above preferred)
Excellent written and spoken communication
Project coordination experience preferred
Strong acumen in data analysis, reporting, time management, and organizational skills

168

Quality Assurance Specialist Resume Examples & Samples

Generate and manage trending quality scores and relevant data while providing reports to stakeholders
Share best practices with team members
May need to work on varied hours based on business needs

169

Quality Assurance Specialist Resume Examples & Samples

Candidate must possess at least a Bachelor's/College Degree in Electrica/Electronics or any Engineering related course
At least 3 year(s) of working experience in the related field is required for this position both Tecnhnical and Non-Technical
Applicants must be willing to work in Cavite Economic Zone
Preferably 1-4 Yrs Experienced Employees specializing in Customer Service or equivalent
Full-Time positions available

170

Quality Assurance Specialist Resume Examples & Samples

Ability to identify, set, and follows priorities
Strong PC and data entry skills
Working knowledge of office productivity software such as word processors, spreadsheets, databases, schedulers, etc
Ability to communicate effectively with employees, clients, and others
Character to maintain strict confidentiality
Minimum of 5 years healthcare claim processing experience in a hospital or comparable organization

171

Quality Assurance Specialist Resume Examples & Samples

Ability to independently perform receiving, in-process and outgoing product audits
Ability to use, calibrate and interpret Quality testing tools, gauges and calibration equipment
Ability to use and interpret Engineering drawings, purchase orders and specifications
Familiar with Statistical Process Control (SPC)
Assist with auditing and maintaining the ISO system of quality management
Ability to recognize and contribute to improvement opportunities

172

Quality Assurance Specialist Resume Examples & Samples

Performed Batch Record Review for Product Disposition
Create, maintain and collect C of A for purchase specifications
Analyze data and compare with the existing specification in the batch record and QC test sheets
Maintain and organize all records by scanning documents
Review labeling materials such as labels and product inserts for accuracy
Issue batch records for production
Release In-process and Finished Product
Maintain Finished Product batch/lot number database
Author Deviation Reports and Corrective and Preventive Action for manufacturing deviations from established Standard Operating Procedures
Review change control documents
Perform other Quality Assurance function such as batch record issuance and change control
BS/BA in field of science such as chemistry, microbiology, biology and biochemistry
Minimum of two years of experience and a strong working knowledge in ELISA testing

173

Quality Assurance Specialist Resume Examples & Samples

Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under general supervision
Qualified candidates must have experience in call center or customer service environment with emphasis on quality improvement. Strong interpersonal skills with ability to be self-directed and an attention to details. Knowledge of Microsoft Office, E-mail and other applications
Experience with multiple quality monitoring systems for full service contact center
Specific experience with designing the quality monitoring process including measurements, forms and agent feedback
Assist in the design of the call monitoring process/form
Listen and score recorded calls (at least 3 calls per agent/month)
Coach agents in the proper contact etiquette as prescribed in the quality process
Work with supervisors coaching agents in prescribed contact handling
Work directly with the Patient Assistance Center manager in developing the forms & scoring process methods
Provide reporting and trending analysis of the contact handling. Identifying areas of overall center training needs as well as individual development needs
Document (& maintain document control) the contact handling processes for all contact types (calls (inbound & outbound), emails, chats, and social media). Measure those processes and provide consultation on improvements
Ability to defuse escalated calls and deal with dis-satisfied patients/customers in a way that would significantly improve the patient experience
Ability to provide both immediate feedback as well as long term guidance in call handling to agents, supervisors and team leads
Works with the training group providing data based training needs for the center based on call trending topics
The ability to maintain friendly, cordial relations with all clients and employees
The ability to maintain friendly, cordial relations with all clients and employees; maintain a positive work atmosphere by acting and communicating in a manner that results in a positive work relationship with customers, co-workers and managers
Ability to comply with ATI standards of operations

174

Quality Assurance Specialist Resume Examples & Samples

Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements. Evaluates responses to quality system nonconformances to ensure that the appropriate root cause, corrective and preventative actions have been identified. Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners
Processes nonconformance, deviations, complaints and corrective/preventive action records to support material dispositions, audit observations and process improvements
Develops, analyze, trends, maintains & reports department metrics
Working knowledge of QC, Manufacturing & Inventory processes
Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential. Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs
5-8 years related quality experience
Quality certifications recommended

175

Quality Assurance Specialist Resume Examples & Samples

Film and video industry
Experience in quality control of video tape, film and DCPs
Manufacturing processes at film laboratories and video facilities
Technical knowledge of film, sound and video elements
Computer programs, such as Microsoft Access, Microsoft Excel and Microsoft Word
Enhanced knowledge of film and tape assets
Strong follow up and organizational skills
Working with film, sound and video elements
Work independently with minimal supervision/guidance and achieve expected results
Recognize and promote diversity awareness
Demonstrate mutual respect
Develop and maintain effective business relationships to deliver superior customer service
Collaborate and productively participate in departmental meetings
Commit to department’s mission, vision & success
Adhere to all policies and procedures
Maintain departmental productivity standards
Trouble shoot problems, with proper and timely escalation to lead distributors or manager
Recognize and suggest opportunities for improvement utilizing innovative ideas
Assume responsibility for job/professional development
Sony Pictures Entertainment is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, age, sexual orientation, gender identity, or other protected characteristics
Sony Pictures - NY - Inwood

176

Quality Assurance Specialist Resume Examples & Samples

Clinical lab experience in Chemistry, Hematology, Coagulation or Urinalysis highly preferred
Strong organizational skills, ability to pay attention to detail, good verbal and written skills
Knowledge in operating a PC computer
Must be able to manage multiple job functions and projects with competency as assigned by the QA Manager

177

Quality Assurance Specialist Resume Examples & Samples

Measure employee call-handling performance, based upon call audit criteria, via recorded call monitoring
Perform quality audits on electronic inquiries, measure ticket process performance (gaps), via Remedy Incident ticket tracking tool
Analyze trend report data from audits
Work with management on employee coaching, training and development to enhance or correct the behaviors that lead to excellent customer service
Assist with development of the call center training and QA process
Perform quality reviews on reports, Help Desk procedural documents, program deliverables documents, and other related materials
Administer Customer Satisfaction Surveys, i.e., distribution, collection and analysis of survey results and reporting
Review/update the MBOSC QASP quarterly, or more frequently as needed
Facilitate Quality Assurance Calibration meetings
Experience in an IT Help Desk, customer service environment, and/or business process/technical support
Experience in a Quality Assurance environment in a contact center or the service industry
Experience in measuring performance and providing performance feedback
Strong analytical, organizational, verbal and written communication skills
Experience in procedure development and process improvement
Experience working with the Centers for Medicare & Medicaid Services (CMS)
Experienced working with government contracts
Knowledgeable in Contact Center/Customer Service best practices
Experience with Microsoft SharePoint
Experience with the AVAYA Call Management tool
Experience with Remedy or ServiceNow

178

Quality Assurance Specialist Resume Examples & Samples

Disposition of Clinical Batches for use in clinical trials
Review of batch documents for label release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements
Deviation and change handling for packaging, lab investigations and related records
Act as contact person for complaints and temperature excursions
Ensure quality and compliance of all qualifications documents
On behalf of Manager Quality Systems, review and approval of specifications for clinical use and of method validation summaries
Preparation and implementation of procedures related core tasks
Issue reports summarizing deficiencies and work with areas to execute remedial action
At least 1-3 years of experience in clinical supplies packaging and/or labeling operations
Documented experience working within a GMP-regulated environment in the Pharmaceutical or Medical Devices industry
Analytical and structured working style; strong attention to detail
Independent; ability to effectively work as part of a multidisciplinary, international team
Strong organizational and time management skills; used to cope with tight timelines
Familiarity with MS Office applications
Fluency in English, additional German language are required

179

Quality Assurance Specialist Resume Examples & Samples

Fluent Russian & English language skills spoken and written
Previous and proven experience of monitoring calls/emails
Experience of delivering coaching sessions in ways which facilitate performance improvement
Proven ability and experience in the use of MS Office including Outlook, Word and Excel
Strong team player
Strong interest and passion for video-games

180

Quality Assurance Specialist Resume Examples & Samples

Provide Quality Assurance support to Elanco Medicinal and Non-Medicinal products. This may include but not limited to the following: parenteral, solid oral dose, non-sterile liquid, premix, API, implant, and EPA/parasiticide products
Execute approved quality procedures applicable to the EEM organization and quality function: product documentation review, product release, deviation review/approval, CAPA effectiveness monitoring, change management, laboratory investigation review/approval, complaint investigation review/approval
Ensure completion of training per approved curricula
Support reporting of metrics according to local procedures
Coordinate complaint investigation requests with contract manufacturers; review/approve complaint investigation reports
Elevate issues such as major/critical deviations, stability OOS, complaints to Hub QA lead as per approved procedures
Provide quality support for tech transfers, ensuring change controls are approved and
Ensure GMP records are retained according to the Global Records Retention Schedule and local procedures
Additional project-based essential QA support functions as assigned
5 years experience in a regulated industry, including experience in quality assurance covering areas such as batch release, process deviation/CAPA investigations, DP / API manufacturing & testing and investigation processes and supplier quality; or technical services with a demonstrated quality mindset
Associate Degree in a scientific area with 10 years experience in a regulated industry, including experience in quality assurance covering areas such as batch release, process deviation/CAPA investigations, DP / API manufacturing & testing and investigation processes and supplier quality; or technical services with a demonstrated quality mindset
Support inspection readiness, including the participation of health authority audits
Thorough knowledge of global cGMP requirements

181

Quality Assurance Specialist Resume Examples & Samples

Create and execute test strategies for FLVS products to identify and correct any defects
Identify quality control risks so the appropriate measures can be taken by the product team
Detect and catalog defects with appropriate detail so they can be resolved quickly and effectively
Run manual and automated tests on products to assure any new functionality does not negatively impact the end user experience
Proactively engage in professional learning regarding the QA and Software Testing industry, FLVS tools and user base to strengthen individual contribution to the team
Review and provide meaningful feedback on work products from the Curriculum Development Life-Cycle
Document and communicate test results to project team and management
Meet professional obligations through efficient work habits such as, meeting deadlines, honoring schedules, coordinating resources and meetings in an effective and timely manner, and demonstrating respect for others
All work responsibilities are subject to having performance goals and/or targets established
One year experience in the web development industry including testing and/or programming
One year experience with web or desktop application technologies
One year experience testing on mobile devices
Strong interpersonal and customer service skills
Ability to work with/for multiple employees and meet deadlines
Knowledge of and ability to apply software support and troubleshooting methodologies
Knowledge of technology solutions for the Internet browsers and web applications on personal computers and mobile devices
Understanding of contemporary quality management principles and practices and the ability to apply them to a wide variety of projects in a fast‐paced business environment
Knowledge of functionality, compatibility, usability, reliability, exploratory, and load/stress testing practices
Ability to create and execute QA and testing processes on systems, networks, hardware and software
Ability to interpret data that gauges the effectiveness and efficiency of processes, customer satisfaction and product/service quality

182

Quality Assurance Specialist Resume Examples & Samples

Reviews less complex testing (e.g. routine study data), advancing to more complex testing (e.g. validation data)
Reviews less complex projects (e.g. review of study spreadsheet)
Reviews final Histopathology reports to ensure an accurate reflection of the raw data
Performs a review of Histology study materials to ensure that the work is accurately reflected in the raw data
Reviews and understands applicable sections of sponsor protocols for GLP studies in order to perform inspections with competence. Ensures that inspections are properly documented, and if applicable, findings are reported as required
Periodically submits written status reports on GLP studies to management and the Study Director as required
Assists with regulated or quality client audits, and FDA inspections
Performs and documents internal facility audits and in-phase study inspections
Determines that no deviations from standard operating procedures or approved protocols were made without proper authorization and documentation
For GLP studies, maintains a copy of the Master Schedule
Maintains copies of client protocols for regulated studies as required
For GLP studies, prepares and signs Quality Assurance Statements
Reads, understands and follows all QAU SOPs
Reads, understands and follows the IDEXX Safety Manual
Other duties as assigned by the QAU Manager
1-2+ years of experience in biomedical research and/or clinical/histology laboratory preferred
Experience working in a laboratory environment regulated per FDA GLP 21 CFR part 58 and/or GCP (VICH-GL9) guidelines preferred
Knowledge of FDA GLP 21 CFR part 58

183

Quality Assurance Specialist Resume Examples & Samples

Schedule, conduct and report results of supplier quality audits in Europe and follow up on non-conformances to ensure effective resolution and timely closure
Track ongoing supplier quality performance and provide recommendations for improvement based on trends
Track product return rates to identify and drive continuous improvements in overall product quality
Lead regional quality team meetings to investigate, coordinate and track product quality issues and drive corrective actions
Follow up on all product quality related issues and non-conformances to ensure corrective and preventive actions are properly implemented
Assist in the resolution of customer escalated issues related to product quality
Compile monthly reports (DOAs, return rates, etc…)

184

Quality Assurance Specialist Resume Examples & Samples

Works on QA initiatives and projects with support from the Internal Audit Quality Assurance & Methodology – VP
Responsible for executing the full life cycle of the Quality Assurance Review (QAR) process, including preparing individual QARs for each audit indicating report rating and areas for improvement, tracking improvements through the lifecycle of future audits, critically evaluating audit testing programs and related fieldwork in line with key regulatory requirements to ensure comprehensive coverage, and recommending changes to existing practices to support key requirements
Assist the IA QA & Methodology VP in driving and executing the quarterly Audit Issue Verification process, including planning/ scoping, actively participating in fieldwork execution (handling the more complex/ higher risk issues) and preparing the quarterly reporting for distribution to senior management
Manages internal initiatives and key projects as assigned, relating to emerging regulatory topics, industry best practices, etc
Provides assistance with regulatory management matters, including examination requests, results, and deliverables
Minimum 5 years of Audit experience required
Minimum 2 years’ experience in Quality Assurance function and/ or proficient with IIA standards
Excellent interpersonal and collaborative skills; high ethical standards with demonstrated integrity, tact, and diplomacy
Strong written and verbal communication skills to deliver high quality, actionable feedback on a variety of issues to Internal Audit management and staff and experience in facing off with senior management on critical issues
Experience working closely with regulators
Bachelor’s degree in Finance, Accounting or related field required; CPA, CIA, CISA, CFE or other related professional certification a plus

185

Quality Assurance Specialist Resume Examples & Samples

Must be in a related class or have experience in Food Safety and Quality Assurance practices
Must be willing to work 40 hours per week, including weekends, evenings and holidays
Experience in culinary and hospitality industry preferred, not required
Light lifting up to 50lbs. required
Must be able to stand, kneel, and squat for extended periods
Must be able to communicate in a professional and efficient manner both in written and verbal formats
Must be professional, energetic, self-motivated, and have the ability to motivate others, and have a positive attitude
Must lead by example regarding grooming, safety, cleanliness, and appropriate conduct at all times

186

Quality Assurance Specialist Resume Examples & Samples

Audits work performed by assigned business unit to ensure records kept in any records platform sucn as SAP, GIS or Mobile Data are consistent, complete and accurate
Performs Quality Assurance (QA) sampling in accordance with recommended ANSI sampling and inspection standards or other standards as appropriate
Compiles and analyzes data, prepares various reports used to evaluate effectiveness of existing processes and procedures
Communicates the information to company personnel at all levels, including making presentations to management teams
Identifies training needs, develops materials, and conducts individual and group training sessions to build employee competencies
Develops, disseminates and updates procedure and training manuals, reference materials and communicates process changes to support company and department business objectives
Creates and maintains open dialogues with departments, requests information and responds by providing suggestions, alternatives and assistance
Leverages relationships to identify opportunities for improvement and develops solutions to issues
Interfaces with business unit and management to identify, create and implement best practices and ensure consistent quality
Serves as a subject matter expert to research and develop responses for technical questions from division operations employees
Able to support cross-functional task teams, committees and/or industry projects, either as leader or participant
Able to demonstrate strong interpersonal skills and listening ability to communicate effectively with customers, contractors, the public, regulators, elected officials and employees
Able to communicate clearly and effectively, both orally and in writing
Able to solve problems and make informed decisions, using knowledge, logic and good judgment
Able to follow procedures and comply with policies based on the knowledge of the work and the services provided by Gas Operations and CenterPoint Energy as a whole
Able to utilize personal computers and software proficiently such as electronic mail, word processing, spreadsheets, database management and presentation software
Able to handle multiple projects, prioritize and schedule tasks, pay attention to detail and demonstrate good organizational and time management skills
Able to work successfully in a team-based environment and build consensus for ideas
Able to demonstrate and apply knowledge of U.S. Department of Transportation regulations applicable to the utility industry
Able to demonstrate and apply knowledge of SAP, Mobile Data, FileNet and GIS systems to collect data, create reports and monitor records integrity functions
Able to complete complex assignments in a timely manner
Able to motivate self and work with minimal supervision
Able to exercise discretion, tact and good judgment in dealing with customers, the public, regulators, elected officials and employees
Able to provide and maintain a valid driver's license and safe driving record

187

Quality Assurance Specialist Resume Examples & Samples

Support daily lab functions including analytical lab testing of product samples, inspections of raw materials, lab equipment calibrations, record keeping and review, sanitation inspections, and wastewater monitoring
Ability to understand and oversee plant quality systems including but not limited to; GMP’s, traceability, manifesting, sanitation, SDS Management
Support QA Manager as needed
Manifest lot numbers of raw materials
Candidate will be required to generate product holds and maintain holds database
Report and investigate quality related incidents
Support Plant audit ready status for Corporate, BRC, Government agencies or other third party audits
Develop and maintain quality documentation procedures following document control program
Coach plant personnel to maintain all food safety and quality standards
Ability to effectively communicate with Logistics, Production, and Maintenance Teams
Ability to track CCP & CQP Deviations, Quality Incidents, and Security/Food Defense incidents
Bachelor’s Degree required: Science related such as food, agriculture, or enology major preferred

188

Quality Assurance Specialist Resume Examples & Samples

Find and interpret data from the 767 Aircraft Maintenance Manual, Structure repair Manual, Fault Isolation Manual and MEL/DDG requirements
Read and understand aircraft drawings
Monitor and document work accomplishment by aircraft maintenance team
Verify all paperwork (Non Routine Cards/Task Cards) and computer data are complete accurate and up to date
Witness or verify operational/functional test of aircraft systems and components, as required, per aircraft maintenance manual procedures
Ensure certification of tools, test equipment and personnel are current
Work with the Customer on process or job related issues as required
Work with other employees to improve functions, methods and procedures. Provide on the Job Training as required
Conduct periodic Audits
Work under general supervision
Work in rotating shifts, 5 days a week from Monday to Saturday
Minimum of 3 years’ experience on flight line or base maintenance. Boeing models of aircraft are preferred
Minimum of 2 years’ as a Quality Assurance specialist supporting maintenance operations. Specific experience on tanker systems is preferred (707, KC-135, KC-10, 767)
Available to be qualified for fuel tank entry
Understanding of Maintenance Plan Document, Aircraft Service Bulletins, FAA Airworthiness Directives’ and Service letters
Experience in reading and interpreting engineering and maintenance technical information
Familiarity with Military Customers is a plus
Previous experience/certification with NDI inspections (dye penetrant) would be preferred
Fluency in English both written and spoken
Proficient in Microsoft Office suite
Familiarity with Boeing web based Information Systems such as: My Boeing Fleet, and a technical inquiry request systems, are a plus

189

Quality Assurance Specialist Resume Examples & Samples

Accountable for setting and maintaining quality standards for Government and awarding body audit purposes, ensuring that we continue to be registered as a training provider, are able to draw down Government funding and to minimise the occurrence of poor inspection ratings
Accountable for ensuring that the UU apprentice programme is inspection ready at all times to minimise the risk of disruption to learning activities on the notification of inspection
Accountable for the implementation of quality improvement processes and tracking systems to ensure that achievement of performance targets are being met and can evidence the impact on learners to management and regulatory bodies
Accountable for the management of quality improvement processes (e.g self-assessment, action plans and performance review meetings) working in collaboration with all internal curriculum areas and external providers to ensure compliance with regulatory bodies and the delivery of high quality programmes
Accountable for ensuring that underperforming programmes have robust actions plans and clear corrective actions so they can demonstrate improvement and evidence impact on learners
Accountable for assessment and observation and coaching of staff with regard to best practice quality processes to enable them to improve their performance and enable UU to work towards a good or outstanding OFSTED report
Accountable as the UU point of contact with awarding bodies for visits and inspection ensuring that assessment and internal verification procedures and practices are in place and being adhered to in line with regulatory and awarding requirements to minimise the likelihood of sanctions
Accountable for the annual development of a self-assessment report and delivery of a continuous improvement plan to demonstrate improvement practices are in place and are being delivered to regulatory bodies
TAQA Lead Internal Quality Assurance Qualification or equivalent
TAQA Assessor Qualification or equivalent
Thorough understanding of the Internal Quality Assurance processes and the ability to deliver continuous improvement
Extensive knowledge of the education sector
Thorough understanding of OFSTED audit requirements and common inspection framework
Thorough understanding of Apprenticeship frameworks and standards
Experience of dealing with awarding body requirements for accreditation and compliance
Ability to analyse data and identify trends and areas for interrogation
Knowledge and understanding of good teaching and learning practices
Proven ability to design, implement and review quality procedures
Extensive knowledge of Microsoft Excel
Power point experience and the ability to deliver presentations
Knowledge of the current Apprenticeship reforms
Certificate in Education

190

Quality Assurance Specialist Resume Examples & Samples

Conducts audits or activities in area of expertise, e.g. reviews computer system validation data, lab investigations, root cause analysis or total Quality Management
Participates in inter-departmental meetings and contributes to policy-making decisions
Provides training for QA and/or laboratory staff
Utilizing QA checklists, evaluates content of reports and compliance with reporting criteria
Verifies accuracy of analytical results and sample identification, inventory and submit data to archives
May require knowledge of chromatography, immunochemistry or statistics Thorough knowledge of GxP and appropriate regional research regulations and guidelines most commonly for the Central Labs CAP/ CLIA or New York State
Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management

191

Quality Assurance Specialist Resume Examples & Samples

Promote implementation of manufacturing controls by developing and facilitating use of standardized batch record templates
Perform document review/approval on all new/revised batch records
Perform production Batch Record review, product release, and investigate discrepancies
Address document issues with production supervisors, quality management, and other appropriate groups
Monitor document adherence to quality and good documentation practices standards, report associated metrics and recommend batch record improvements per spot-check audits
Provide guidance and training to manufacturing and other functions in implementing good documentation practices; assist in setting site policies for GDP
Archive, store and maintain all records to comply with Corporate and Site policies
Perform other duties as may be required or necessary
2-5 years of relevant experience in a Quality Assurance or related role
Demonstrated use of Quality tools/methodologies
Good working knowledge of FDA, GMP, ISO 13485, and ISO 9001 regulations
Good organizational skills and ability to multi-task, drive for results and make sound business decisions independently
Strong knowledge of using Microsoft Excel and Word required

192

Quality Assurance Specialist Resume Examples & Samples

Erection of reinforced concrete & structural steel during installation and testing of reinforced concrete, slab, and structural steel construction. Manages the quality control staff and all specialty subcontractor inspection entities to ensure all disciplines are in compliance with applicable owner/architect and government specifications, codes, regulations and requirements
Erection of pile foundation
Implements and/or manages the keeping of quality control records and ensures that required reporting is accomplished
Define corrective measures for problem areas
Reports results to the respective superintendent(s) in an expeditious manner and acts as catalyst for follow-up corrective actions and re-inspection when deficiencies are discovered

193

Quality Assurance Specialist Resume Examples & Samples

Do basic application testing
Prepare automated tests
Generate reports
Tight cooperation with Development and Solution Management

194

Quality Assurance Specialist Resume Examples & Samples

Good English is a plus
Candidate must possess at least a Bachelor's/College Degree, any field
Good grip on soft skills and customer orientation
Strong analytical and listening skills. Ability to build and maintain interpersonal relationships
Preferably 1-4 Years Experienced Employees specializing in Customer Service or equivalent
Full-Time position(s) available

195

Quality Assurance Specialist Resume Examples & Samples

Develop quality assurance plans, assess risk, develop test strategies, perform workload analysis, identify and create test cases, identify and structure test procedures, review and assess test coverage, establish and maintain test data sets, oversee successful execution of test procedures, verify test results, analyze defects and submit change requests
Define and track quality assurance metrics (i.e. Defect densities / open defect counts)
Ensure system development meets the functional and technical requirements
Create and execute functional system test plans that imitate real – world system use
Complete special assignments when assigned
3+ years of progressive software product testing and development experience in the software or information technology industry
Bachelor’s Degree (or higher) in Computer Science, Engineering, or a related field
Knowledge of the Pharmacy Industry

196

Quality Assurance Specialist Resume Examples & Samples

Demonstrate expert knowledge of processes and related systems to effectively perform responsibilities
Perform and or ensure completion of quality review check on outgoing work e.g., proof data entry, correspondence, and other tasks within immediate team to ensure quality, accuracy, and consistency Identify and assist with development of support materials for team use, e.g., training manuals, job aids, and views in databases
Prepare, analyze and interpret complex reports information and formulate conclusions
Conduct daily audits reviews
Minimum of 1 year experience working with Microsoft Office
Active User of Social Media
Bachelor s Degree preferred
Ability to proactively submit suggestions and take action based on data analysis
Bilingual English Spanish is preferred

197

Quality Assurance Specialist Resume Examples & Samples

Actively contribute to testing all components
Provide sign offs on releases, record & retain test results, work with Release manager to deliver releases to production
Actively contribute in sprint planning, support ( second line)
Work on automated testing of all components
Train other QA resources globally
Good problem solving & analytical skills
Knowledge & experience with Linux
Good communication & interpersonal skills
Ensure that there is clear accountability for all areas of the testing lifecycle from the Unit testing phase through UAT
Work Closely with Production Support to ensure that they are aware of any known or existing defects prerelease
Communication of total testing health to the major stakeholders of the release initiatives
SME in valuations & risks for Equities products
Any prior development experience
FRM or equivalent certification
Ability to write/comprehend shell script, Python, JavaScript
Bachelor's degree in computer science or equivalent training required
4-6 years of experience in quality assurance role

198

Quality Assurance Specialist Resume Examples & Samples

5+ years of customer service experience, preferably in a call center environment
1+ year of quality assurance experience
5+ years experience with Microsoft Office
3+ years of training experience, especially with the following training methods
Must be able to communicate clearly and comfortably with customers, coworkers, managers
Excellent written and verbal communication skills as well as active listening skills
Ability to work to a deadline and in fast paced environment
Performance Management, Teamwork, Quality Management, Supervision, Product and/or Program Knowledge

199

Quality Assurance Specialist Resume Examples & Samples

Determines disposition of raw materials and/or final product to ensure compliance
Reviews completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Participate in and perform raw material activities according to approved procedures
Providing technical expertise in quality risk management to a broad base of customers throughout the organization
Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory and SOP requirements
Deviation investigation, review and approval
Requires BS/BA in scientific discipline or related field with 1 year of relevant work experience in pharmaceutical or related industry
Relevant experience may be considered in lieu of educational requirement
Level of position will be determined based on skills and related experience

200

Quality Assurance Specialist Resume Examples & Samples

Search for and listen to call recordings from various departments (e.g., Sales, Lead Generation, Retention, Medicare, etc.) on a daily basis
Evaluate and score recorded calls based on various criteria (e.g., compliance, accuracy of information provided to the customer, professionalism, etc.)
Identify strengths, opportunities for improvement, and any compliance violations in customer interactions
Provide detailed, insightful, and constructive feedback on evaluations
Enter daily quality assurance (QA) data into Excel spreadsheets in order to track scores and trends
Search for and export call recordings containing verbal authorizations (under the HIPAA Privacy Rule) and extract said verbal authorizations
Search for and export call recordings containing voice signatures and extract said voice signatures
Track daily product sales and record the type of signature on each account
Listen to recorded voice signatures to confirm validity
Upload voice signatures to designated SFTP
Generate verification letters to be sent to customers whose accounts are missing both electronic and voice signatures
Ensure that each insurance policy has a signature, verification letter, or both
Correct any inaccurate customer information in the CRM system
Monitor inbound and outbound calls in real time
Search for, export, and send call recordings to the Quality Assurance Supervisor on an ad hoc basis
Perform other duties as directed
High school diploma or high school equivalency credential (e.g., GED credential) required
Minimum of six months' call center experience
Proficient in Microsoft Office Suite (Word, Excel, Outlook)
Strong verbal, written, and interpersonal communication skills
Thorough knowledge of correct English usage and demonstrated ability to use appropriate spelling, grammar, and punctuation
Effective organizational and time management skills with the ability to work effectively under pressure and adhere to deadlines
Ability to handle multiple tasks in a production-driven environment
Ability to adapt well to new situations and shifting priorities
Must be flexible with schedule
Ability to type 45 words per minute or more
QA experience in a call center environment preferred

201

Quality Assurance Specialist Resume Examples & Samples

Monitors and evaluates the quality of inbound and/or outbound interactions with customers
Documents quality issues and scores performance measures for management review
Documents and provides feedback for improvement to internal customers and management
Reviews monitoring standards, processes and procedures
Researches and validates quality monitoring results for presentation to management
Organizes, analyzes, and summarizes quality monitoring data and prepares recommendations for improvement of business processes and procedures
Participates in quality measurement calibration sessions
High school diploma/GED required; Associate’s degree preferred
2+ years of call center and/or quality assurance/improvement experience required, or an equivalent combination of education and experience
Knowledge of quality assurance practices and procedures
Written communication skills
Computer skills with Microsoft Office (Word, Excel, PowerPoint, Outlook)
Organization and time management

202

Quality Assurance Specialist Resume Examples & Samples

Support of customer group quality systems (Deviation, CAPA, Change Control, Report and protocol reviews, Document review and approval)
Work on minor to moderately complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercise latitude in determining objectives and approaches to assignments

203

Quality Assurance Specialist Resume Examples & Samples

Good knowledge in STLC and Defect lifecycle
Automation Testing experience using HP QTP/ UFT or Selenium
Proficient in STLC, Requirement analysis and identifying Test Scenarios
Maintenance/up-gradation of existing automation scripts
Knowledge of Test automation framework
Good experience in Agile methodology
3 – 6 yrs (Middle level)

204

Quality Assurance Specialist Resume Examples & Samples

Work with internal groups to ensure timely development of policies and procedures required to ensure that the laboratory and computational environment exceeds relevant State (CA, FL, MD, NY & RI), Federal (CLIA) and professional society (CAP & AMP) standards
Work with internal groups to ensure software validation documentation adheres to applicable State and Federal requirements
Work with internal groups to provide guidance and review of Change Control documentation for software development activities
Ensure that SOPs, worksheets, validations, event logs and CAPAs are reviewed and approved
Ensures proper evaluation and completeness of corrective and preventive plans (CAPA)
Review and approve SOPs and protocols and reports for software validation and other studies
Review and approve Quality records including equipment and instrument maintenance logs, reagent qualification records, instrument maintenance logs, instrument IQ/OQ/PQ
Track and trend planned and unplanned deviations, complaints, and corrective actions
Minimum 2 years Quality Assurance/Regulatory Assurance experience in the medical device or pharmaceutical industry, understanding of product development, quality control and services
Experience in QMS implementations in software engineering and/or bioinformatics settings
Experience in establishing CLIA, CAP and/or QSR Quality Systems
Possess working knowledge of software validation using Agile methodology
Possess working knowledge of applicable local, state and federal laboratory regulations

205

Quality Assurance Specialist Resume Examples & Samples

465048500
Complete Resume
Other supporting documentation as required. Please see the "REQUIRED DOCUMENTS" section and review the applicant checklist link to determine if there are other documents you are required to submit
It is the applicant's responsibility to verify that all information in their resume and documents, whether uploaded or faxed, are received, legible, and accurate. HR will not modify answers/documents submitted by an applicant. **
KNOWLEDGE OF QUALITY ASSURANCE PRINCIPLES, PRACTICES, AND PROCEDURES
KNOWLEDGE OF CONTRACTING AND ACQUISITION REGULATIONS PRACTICES, AND PROCEDURES
ABILITY TO COMMUNICATE ORALLY AND IN WRITING

206

Quality Assurance Specialist Resume Examples & Samples

10% Domestic Travel May Be Required
E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing
All qualification requirements must be met by the closing date of the announcement
One-year probationary period may be required
Travel, transportation, and moving expenses will be paid: No
Bargaining Unit Position: Yes
Recruitment Incentive may be authorized: Yes
Annual Leave for non-federal service authorized: No
Research position: No
Supervisory position: No
To begin, click to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire
Click the Submit My Answers button to submit your application package
To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login,
To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete
Knowledge of principles and concepts of quality assurance
Knowledge of ISO standards and other QMS guidance, directives, policies and practices
Skill in written communication and public relations techniques to represent the Agency at conferences and meetings concerning program objectives and policies, special problems and issues
To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf
Fax your documents to 1-478-757-3144 . If you cannot complete the Application Package online, you may fax all of your materials. The complete application package must be submitted by 11:59 PM (EST) on Wednesday, March 15, 2017to receive consideration
A complete Assessment Questionnaire
Other supporting documents
Veterans Preference Documentation, if applicable
Schedule A Eligibility Letter if you are applying as a Schedule A candidate

207

Quality Assurance Specialist Resume Examples & Samples

464997500
To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process
Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed
Assessment Questionnaire
SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)

208

Quality Assurance Specialist Resume Examples & Samples

Integral role in planning and execution of web campaigns spanning across digital channels
Collaborate with design team on writing and implementing advertising copy for display/search ads, landing pages, and positioning to ensure brand standards and accuracy
Collaborate with internal and external teams to produce, monitor, and optimize multiple digital campaigns
Plan, execute, and measure experiments and conversion tests
Collaborate with internal teams to create landing pages and optimize user experience
Utilize strong analytical ability to evaluate end-to-end customer experience across multiple channels and customer touch points
Assist with weekly forecasting updates and budget flow management, including measuring and reporting performance of all digital marketing campaigns, assessing against goals (ROI and KPIs)
Instrument conversion points and optimize user funnels
Identify trends and insights, and optimize spend and performance based on the insights
Provide thought leadership and perspective for adoption for emerging technologies
Collaborate with agencies and other vendor partners
Bachelor's degree or Master's Degree in marketing or a related field
Minimum 5 years' experience in digital marketing; experience in education marketing preferred
Demonstrable experience leading and managing SEO/SEM, marketing database, email, social media and/or display advertising campaigns
Highly creative with experience in identifying target audiences and devising digital campaigns that engage, inform and motivate
Experience with A/B and multivariate experiments
Solid knowledge of website analytics tools (e.g., Google Analytics, NetInsight, Omniture, WebTrends)
Working knowledge of ad serving tools and the media buying space (DSPs, DMPs, SSPs)
Experience in setting up with CRO platforms (Optimizely, Google experiment)
Strong analytical skills and data-driven thinking
Up-to-date with the latest trends and best practices in online marketing and measurement

209

Quality Assurance Specialist Resume Examples & Samples

Inspects food, distributor, processor, and manufacturer warehouses to ensure that vendor requirements/specifications are being maintained
Conducts citywide routine school inspections and follow up visits on a daily basis. Responsible for visiting/inspecting NYC locations serviced by School Food
Handles product samples for lab testing, when necessary
Relay reports and findings to field
Inspects food to ensure compliance with terms of contracts and standards associated with grading and stamping
Ensures that microbiological lab reports are received in a timely manner
Communicates with brokers and manufacturers
Releases, rejects, or condemns donated commodities at the distributor and/or school level
Enters data associated with donated commodities in computer programs
An associate degree from an accredited college, including or supplemented by 12 semester credits in food technology, and three years of satisfactory full-time experience as described in "1" above; or
A baccalaureate degree from an accredited college, including or supplemented by 24 credits in agriculture or related field, and one year of satisfactory full-time experience as described in "1" above; or
A satisfactory combination of education and/or experience equivalent to "1", "2" or "3" above. Undergraduate college credit may be substituted for experience on a basis of 45 semester credits from an accredited college for one year of experience. However, all candidates must have a four-year high school diploma or its educational equivalent and at least one year of satisfactory full-time experience described in "1" above
For all positions

210

Quality Assurance Specialist Resume Examples & Samples

Partner cross functionally with design, product development and sourcing teams to understand potential product liability, compliance & performance requirements in order to incorporate necessary testing
Provide risk assessments during tech pack creation and analyze samples; understand and keep up to date with chemical restrictions and regulations for textile apparel products in North America and other countries as required
Determine appropriate test methods, standards and tolerances to deliver the best possible products for our brands
Research new test methods and keep up-to-date with industry standards
Understand labeling regulations for textile apparel products in North America and other countries as required, including care/content information and bilingual labeling regulations

211

Quality Assurance Specialist Resume Examples & Samples

Run regression tests
Complete manual checklists for web applications
Communicate with analysts and programmers about formal testing plans, problems, and results
Devise creative solutions to problems
Typically requires a bachelor’s degree or equivalent and two to four years of related experience
Experience working with JAVA based applications
Ability to work in team environment and also independently when needed
Prefer but not required, CDA knowledge for testing efforts (CDA certified, not required)

212

Quality Assurance Specialist Resume Examples & Samples

2-4 years of experience working in a quality assurance role either supporting an ISO or CMMI quality management system
2-4 years of experience writing, editing, and reviewing processes/procedures/work instructions
2-4 years of experience in call center quality assurance, coaching, reviews, and evaluations
0-2 years of experience working with Microsoft SharePoint
0-2 years of experience utilizing Lean Six Sigma methodology or LSS Green Belt Certified
2-4 years of experience administering a Microsoft SharePoint portal
2-4 years of experience creating Microsoft SharePoint workflows
0-3 years of experience as a technical writer
2-4 years of experience coordinating quality initiatives

213

Quality Assurance Specialist Resume Examples & Samples

The QA Analyst will work side-by-side with development and business partners to determine optimal test coverage and ensure high quality software is delivered to our customers
The analyst is expected to act as lead on the creation, maintenance and execution of test scripts, oversight of execution and defect management and other specialty testing activities in the areas of manual and automation testing, test environments, data conditioning and application specialties specific to Mobile
Identifies and develops ways to improve the quality, capability, or efficiency of the testing process
Consults on estimations, impact assessment and risk assessment of development changes
Bilingual – English/Spanish
Minimum 4+ years of hands-on work experience in SDLC process with a focus on test planning, test execution and defect management
Experience in building testing frameworks, tools and automation within a large scale enterprise environment using Selenium, TestNG, QTP and/or similar frameworks
Demonstrated ability to self-direct day-to-day activities and multitask effectively
Strong experience working within an Agile testing environment
Working knowledge of QC, Mobile Device cloud, Selenium, Sonar, Jenkins
High technical competence with current hands on coding skills and understanding of Java/J2EE, C++
Familiarity with bank systems and data conditioning

214

Quality Assurance Specialist Resume Examples & Samples

Routine monitoring of incoming products from suppliers to ensure proper handling and consistent standards have been met by the vendor
Training of all employees in proper food handling techniques required to maintain quality throughout pick and delivery cycle
Initiate best practice receiving and handling practices for all Fresh, Dairy & Bread products to ensure consistency of quality is maintained through the distribution process
Analyze controllable data and provide input into preventative actions
Assist in Customer Complaint investigations and contribute input into corrective actions
Create audit procedures for AIB compliance
Maintain accurate documentation, databases and relevant reports
A degree or diploma or 3-5 years experience in a Food Science discipline
Experience and understanding in the handling of Fresh, Dairy and Bread products
Strong interaction, organizational and computer skills
Understanding of AIB and/or HACCP Quality Systems and Regulatory requirements
Demonstrated hands on approach and ability to work with minimal supervision
Continuous Improvement experience
Ability to lead and train others in the proper handling of product to maintain quality

215

Quality Assurance Specialist Resume Examples & Samples

Providing guidance to research operations on the interpretation of regulatory requirements (standard/ policies/ procedures) related to quality assurance and GCP
Performing quality functions and executing quality programs to support CRO processes
Assisting in the preparation, hosting, and follow-up of Sponsor audits/ assessments and regulatory inspections
Participating in the development and/ or review of standards, policies, procedures, and work instructions to support the quality management system and CRO processes
Conducting internal, vendor, and site audits, including planning, executing, reporting, follow-up
Providing guidance and support for deviations and corrective and preventive actions required by CRO activities
Developing quality plans and/ or audit schedules as appropriate
Identifying areas of deficiency and trends in quality and escalating to appropriate colleagues
Developing, modifying, and utilizing tools to track and trend compliance issues
Developing timelines to ensure timely and appropriate follow-up in areas of deficiency
Maintaining records to support quality processes and audits
Educating, training, and mentoring staff in quality improvement methods
Attending training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends
Participating in divisional improvement efforts
Performing related work as required
Travel up to 10%, as assigned
FDA regulations and GCP guidelines
Pharmaceutical, biologics, CRO, and/or medical device industry
Professional writing and communication skills
Computer skills, including MS Word, Excel, Outlook; electronic data capture systems, electronic quality management systems
Detail-oriented and meticulous
Organized, ability to prioritize
Analytical
Healthcare research or other science-related field
Quality Assurance, quality management, or quality auditing
Working in a CRO or Sponsor environment preferred

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Quality Assurance Specialist Resume Examples & Samples

Conducts auditing of internal Quality Systems and may assist in the modification of QMS documentation to assure that customer and regulatory requirements are met
Participates in improvement teams in the development and evaluation, analysis of root cause and corrective action processes
Participates in the effort to address and reduce customer complaints through effective root cause investigations and corrective action as required
Participates with site initiatives, participating on teams in order to drive best practices
Collects and analyzes organizational quality metrics and performs reviews to evaluate results
Associates degree from a recognized institution or 1 - 3 years of working experience in a manufacturing environment or equivalent professional knowledge. Aerospace and/or Medical Device experience a plus
Basic understanding of problem solving methods – i.e., 8D, root cause analysis, and the associated statistical tools used to analyze problems, evaluate and complete improvement projects, helpful
Basic understanding of AS9100, ISO 9001, or ISO 13485 standards, preferred
Creative problem solving, flexibility and good negotiation skills
Ability to multitask and drive practical results to a timely conclusion
Demonstrated proficiency with computer skills: MS Office Applications, Enterprise database systems or equivalent
Ability to speak in front of small audiences
Must be US Persons based on ITAR definition (US Citizen or Permanent Resident)*
This position is expected to be exposed to information which is subject to US export control regulations, i.e. the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR). All applicants must be U.S. persons within the meaning of U.S. regulations

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Quality Assurance Specialist Resume Examples & Samples

465601000
Travel throughout U.S. will be required
Please do not send/fax/courier/email any applications or resumes to the National Guard Human Resources Office. You must apply on-line or fax your application to the fax number listed in this announcement with the prescribed Cover Letter. The Human Resources Office can only process materials received through USAJOBS
Your resume and any other documents specified in the Required Documents section of this job announcement
You must click the Submit My Answers button to submit your application package when you are done
If you submit more than one Qualifications Assessment Questionnaire for this position, the most recent one
Current Resume. (Be sure to list your duties and responsibilities as they relate to the specialized experience as listed above.)
Completed and Signed NGIL 73 (Be sure list all AFSC's or MOS's held during your military career)
Http://www.il.ngb.army.mil/PDFs/EmploymentForms/NGILForm73.pdf
Transcripts (If using education to substitute for experience, you must submit transcripts.)

218

Quality Assurance Specialist Resume Examples & Samples

Assist in maintenance of the quality standard in accordance with BS EN ISO9001:2008 and EU Directives
Assist in continual monitoring of the quality system in accordance to BS EN ISO9001:2008 and EU Directives
Provide support to ensure compliance with legal requirements and regulatory authorities (MHRA and Home Office)
Undertake and coordinate internal audits to ensure compliance with ISO and MHRA requirements
Monitor and conduct internal and external auditing activities
Advise Senior Managers of any non-compliance to the applied standard and ensure corrective/preventative actions are implemented in a timely manner
Maintain documentation in relation to the relevant standards, compile the Quality Report and provide support to the Head of Quality, Training & Personnel
Degree or equivalent in life science or relevant field
Minimum of 5 years’ experience within the pharmaceutical industry
Comprehensive knowledge of the BS EN ISO9001:2008 and relevant EU Directives
High standard of technical, organisational and IT skills
Professional communication and interpersonal skills

219

Quality Assurance Specialist Resume Examples & Samples

Knowledge of technical requirements
Knowledge of quality assurance methods, principles and practices
Skill in investigating, analyzing and developing recommendations
To verify your application is complete, log into your USAJOBS account, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process

220

Quality Assurance Specialist Resume Examples & Samples

Mastery of QA, quality control and proficiency testing concepts, operating principles, regulations and methodologies to evaluate and resolve complex conditions applicable to the forensic laboratory and administrative operations and procedures
Knowledge of inspection, test and measurement techniques, including statistical analysis and sampling techniques, to study QA and quality problems in a forensic laboratory environment
High degree of skill in the application of principles of forensic science to analyze and resolve very complex and sensitive QA and proficiency testing problems in broad and diverse forensic disciplines
Effective oral and written communication skills to interact with others, facilitate team operations, prepare reports, policies, and other documentation and make presentations to management and others
Interpersonal and leadership skills necessary to effectively counsel and guide associates in their work, to provide or arrange for the one-on-one training as necessary in order to improve individual work performance and to establish and promote an effective and mutually beneficial work environment

221

Quality Assurance Specialist Resume Examples & Samples

Responsible for completing all related activities associated with product release for the assigned manufacturing department(s)
Review / Approve document revisions
Ensure thorough investigation and closure of deviations
Initiate holds and complete dispositions
Approve change controls and complete implementation plan
Conduct on floor support to ensure compliance during production activities
Complete blue print and legend review annually
Complete outline and dossier review annually
Support routine internal audits and self-inspections
Support additional projects as needed related to the Quality Assurance Department
Experience working in a cleanroom environment
Experience with aspects within sterility assurance (environmental monitoring, aseptic process simulations, water systems)
Experience in a USDA regulated environment
Sufficient experience in FDA and/or USDA regulated industry
Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications

222

Quality Assurance Specialist Resume Examples & Samples

Lead or contribute to projects in the development, execution, and data analysis of assay validation, laboratory equipment qualification, and method improvement studies in the QC laboratories. Apply and correlate method validations with targeted manufacturing processes when appropriate. Ensure completion of all protocols and validations in a timely and appropriate manner. Report progress and significance of results to laboratory management or project leaders. Recommend utilization of results or changes in the scope of work (including termination of project)
Lead or contribute to the evaluation of new methodologies and transfers to determine business need and applicability to the area. Provide recommendations for or implement instrumentation upgrades or improvements to drive optimal performance. Prepare project plans to ensure implementation according to required timelines
Write technical memos, reports, protocols, studies and other appropriate documentation to support laboratory validations, investigations and/or objectives
Frequent use and general knowledge of industry practices, techniques, and standards. Provide technical support to the QC Laboratories. Identify and provide resolution to assay and equipment related issues. Provide technical advice to teams involved in the troubleshooting and problem solving activities
Support global standards/strategies in continuous improvements
Comply with control of lab documentation. Review data with application of good documentation practices. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations
Assure compliance with company procedures, quality and regulatory requirements, and regulatory guidance documents including QSR, cGMP, USP, CFR, and compendia literature. Support and implement laboratory systems and/or guidelines to meet compliance requirements
Support regulatory and non-regulatory audits (e.g. Internal Quality Assessment, Corporate, FDA). May serve as a technical expert and interface with inspectors during both internal and external inspections
Review and revise controlled documents as required. Support regulatory submissions /change control requests in a timely manner when required
Proactively lead and/or actively contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support
Provide technical presentations and/or training to QC Laboratories (including management) as needed
Ensure personal training requirements are met and training records are current
Stay current in the technical and compliance field regarding lab instruments and methods
Must demonstrate good leadership, influence, and cross-functional collaboration skills
Must exhibit sound decision-making ability and effective interpersonal skills
Must be able to effectively communicate (both verbal and written) with peers and managers, internal and external contacts
Basic project management, organizational, and time management skills are a must. Ability to manage multiple activities concurrently and ensure they are completed in a timely manner
Ability to prioritize and thrive in a fast-paced environment
Able to effectively problem solve laboratory testing procedures and troubleshoot lab equipment
Ability to analyze complex data and present analysis/outcomes to management
Capable of performing advanced trending and navigating statistical software
Demonstrate good technical writing skills. Able to write effective technical documents
Experience in advanced wet and instrumental methods of analyses. Demonstrated technical expertise and experience in assays and equipment
Knowledgeable and proficient in statistical analysis, quality systems (e.g. change control, exception management, audit processes, validation, etc.) and interpretation of cGMP, CFR, USP, JP, EP and GDP
Experience in government regulations pertaining to pharmaceutical and medical device manufacturing laboratories
Demonstrate effectiveness in ability to train others, encourage empowerment, and drive completion of project and/or milestone commitments
Proficient in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, Power Point)
Proficient in a wide variety of lab application software
Biology, Protein Chemistry experience preferred

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Quality Assurance Specialist Resume Examples & Samples

Act as primary QA contact for the LSM Compliance team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance. Including participation in on-line trouble shooting and investigations as needed. Perform QA Assessment and Approval of Global Changes (GCC)
Support quality KPIs by collecting and analysis of data
Create monthly/quarterly reports for metrics

224

Quality Assurance Specialist Resume Examples & Samples

Oversee all QA archived files, including records from QA, Quality Control, Manufacturing, and Validation departments
Assist in the development of Document Control Policies and Procedures
Ensure documentation is processed, formatted, issued, and made effective accurately
Responsible for reviewing Document Change Controls to ensure proper revision control of GMP records
Provide QA backroom support during regulatory, internal, and/or third-part inspections
Oversee document periodic review process
Act as a business administrator for Electronic documentation management systems (EDMS)
Issue Master Batch Records and Log Books for internal manufacturing operations
Ensure proper organization of executed supplier documentation
Maintains and Assigns document numbers, part numbers, and lot numbers
Perform other projects related to improvement of quality systems as needed and required by management
BA/BS and 1-4 years’ experience in document control in biotech or related regulated industry
Experience with EDMS systems, preferably Veeva Vault Quality Docs
Working knowledge of cGMP guidelines
Excellent organizational and time management skills
Ability to identify problems and create solutions
Must be proficient with the Microsoft suite (i.e Word, Excel, PowerPoint etc.) and Adobe

225

Quality Assurance Specialist Resume Examples & Samples

Performs and directs, as applicable, quality assurance activities on a project, communicating with Engineering, procurement, and construction, and other project personnel to ensure management goals and objectives are met
Ensures appropriate project quality program/plan elements are included in project plans, procurement specifications, subcontracts, and scopes of work
Reviews and approves quality-related procedures prepared on the project to ensure compliance with the MCR project quality program/plan
Mentors personnel assigned to the project on quality assurance related topics and activities
Supervises and participates in the project assessments and auditing activities to verify the effectiveness of the MCR quality program/plan
Recommends actions to project personnel to correct observed quality deficiencies
Monitors project Quality Assurance Program (QAP) actions to ensure timely and effective completion, and assists project personnel in closure of corrective actions and investigation and resolution of reportable occurrences
Reviews project schedules for quality-related activities to ensure timely and effective implementation of the MCR project quality assurance program/plan
Identities quality problems, initiates documented corrective actions, and verifies implementation of solutions
Prepares reports on the effectiveness of the quality assurance program/plan implementation
Review QA Program and other relevant documents submitted by subcontractors, as required
Comprehensive understanding of Quality Assurance principles as applied to large construction projects
Able to demonstrate the ability to achieve the task results consistent with requirements for safety, quality, timelines, and resource allowance
Possess strong interpersonal skills and a demonstrated ability to interact positively with others by developing trust, mutual respect and cooperative working relationships
Demonstrate dedication and commitment to ensuring project success and meeting project needs
Demonstrated skills and understanding in the principles of good written and oral communication
Demonstrated understanding of Project Management tools and techniques
Understanding of Engineering Change/ Modification principles
Demonstrated commitment to continuous improvement

226

Quality Assurance Specialist Resume Examples & Samples

Responsible for working with 15-20 properties at a time to deliver on key service offerings for Valet Living Turns
Follows quality checklists to identify, process and correct defects discovered at work sites
Works with building principals, technicians, and other key personnel to complete projects
Communicates with properties regarding job details, drives value-added services
Serves as property and technician retention leader by utilizing effective objectives handling
Responsible for correcting unsafe conditions in work area and reporting any conditions that are not correctable to management immediately
Use cleaning products according to established safety procedures, and instruct others on proper procedure
Valid Colorado driver’s license
Prior experience in service management or property management preferred
Bilingual in Spanish required
Ability to operate company vehicle in a manner consistent with local and state rules and regulations and company policy
Ability to frequently walk, stand, climb, lift, carry, stoop, bend, kneel and reach, lift up to 50 lbs
Ability to operate hand and power tools and work in tiring and / or uncomfortable positions as needed
Ability to work inside or out, or on slippery or uneven walking surfaces, and ladders
Ability to be exposed to hot and cold temperatures and cleaning chemicals

227

Quality Assurance Specialist Resume Examples & Samples

Prioritize workloads to ensure timeliness and quality standards are met
Conduct necessary research and coordination as necessary for all quality assurance audit activities
Validate analysis and outreach activities in accordance to current policies and directives
Thoroughly understand the requirements on all work activities and processes being reviewed
Provide feedback and guidance to staff concerning quality assurance audit results in a manner that is not biased or defensive
Bachelor's Degree, or substitute 2 years of equivalent work experience
Minimum of 1 year of experience in a quality assurance or analytical role, or substitute education
Experience with enrollment transactions
Ability to read and interpret process and workflow diagrams and work instructions
Strong technical problem solving
Experience with State or Federal contracts
Ability to research, evaluate, analyze, resolve, and present solutions to problems
Experience in healthcare standards

228

Quality Assurance Specialist Resume Examples & Samples

Ensuring that products, materials for production, systems and facilities are in state of sustainable compliance with the requirements of GMP and regulatory authorities
Review and approval of changes, CAPAs and NCs
Review and approval of SOPs, WOIs, RARs and other quality controlled documents
Review and release of materials for production specification documentation
Qualification, review and approval of materials for production
Review and release of batch production records, including all supporting documentation (for example, test results)
Compilation of batch dossier for batch release
Experience in quality assurance of biological or pharmaceutical products according to GMP requirements
University degree (FH/BSc/MSc) in natural sciences/medicine/pharmacy or professional scientific, medicinal or pharmaceutical training and several years working experience under GMP
Know how of quality assurance principles (GMP), biological manufacturing processes and risk management
Inspection experience
Strong communication ability and good negotiation skills
Analytical thinking and problem-solving ability
Time and self-management
Multilingual – at least German and English, written and spoken

229

Quality Assurance Specialist Resume Examples & Samples

Quality system management and administration
GMP training program management
Quality and compliance improvement projects
Management of the DCC
BS degree in Chemistry, Biochemistry or a closely related discipline
5-8 years of related QA systems experience is required. Experience in Biotech or a Biopharmaceutical environment is highly desired
A thorough understanding of cGMP regulations and experiences in regulatory inspection is required
Ability to interpret multiple standards and apply to department activities
Ability to interpret and evaluate data and summarize results
Ability to train in the areas of QA, compliance, etc
Knowledge and good understanding of validation
Be open to take on new approaches to establish and maintain effective relationships with co-workers and subordinates
Ability to establish and maintain electronic database. (i.e. deviation, change control, training documents, etc.)
Ability to work in a Windows computer environment
Excellent oral and written skills

230

Quality Assurance Specialist Resume Examples & Samples

Provide the monthly non- conformance information to the Corporate Quality Assurance Manager or their designee
Write and/or revise quality and repair procedures
Conduct audits of shop activities including inbound inspection, outbound inspection, welding, NDT Testing, and in-process inspections
Conduct shop QA audits and review results with shop personnel
Attend Monthly QA shop calls
Support customer visits to repair facilities and conference calls
Review ARI SRM Procedures and develop/perform training with shop personnel as necessary
Assist the plants in the creation, control, and update of local shop procedures as necessary and develop/perform training with shop personnel as necessary
Review and update AAR MSRP’s when Circular updates are issued and develop/perform training as necessary
Conduct ARI audits of assigned facilities as needed
Attend and/or assist customer and regulatory audits when applicable
Review customer procedures and develop/perform training with shop personnel
Audit measuring and test equipment at all facilities
Audit welding procedures and practices
Maintain training and certification records for Railcar Services employees and schedule re-certifications
Assist and audit non-conformances and develop prevention strategies
Work closely with Railcar Services Directors, QA Manager, QA Supervisors, Plant Managers and other plant personnel on quality related matters
Attend industry specific meetings as required
Create and/or assist in the development of new processes and procedures as required by industry development
Perform remote audits of assigned Quality Assurance topics and analyze trends in order to develop preventative measures
Perform investigation of customer complaints
2 year college or equivalent industry quality experience
Experience in quality audits
Procedure / process oriented
Ability to travel 50%
Familiarity with MS Word, Excel and Power Point and Adobe programs
Good customer relations skills
AAR M-1003 quality auditor training (a plus)
Welding familiarity (a plus)
NDT familiarity (a plus)
Office enviroment
Periodic, but infrequent travel
Periodic, but infrequent plant environment
Ability to wear personal protective equipment (PPE) as needed

231

Quality Assurance Specialist Resume Examples & Samples

Assists in scheduling the audit activities by contacting the partners to agree on logistics and participations
Prepares the audit notification and sends them to the partners
Distributes the draft audit report to auditees for factual correctness and understanding and ensures compliance with the deadlines
Distributes the final report distribution & audit certificate along with timelines for CAPA plan
Updates the audit and CAPA tracker
Provides PSMF monthly updates
Provides PSMF monthly as well as quarterly updates to PV compliance team site
Uploads audit records into Soltraqs
Coordinates the CAPA reviews and approvals process
Close monitoring and tracking until the CAPA closure
Provides the deliverables for PSURs and RMPs to GPV

232

Quality Assurance Specialist Resume Examples & Samples

Must have a strong knowledge/understanding of ASD, Traditional Products, Platforms, and Workflows
Must exhibit leadership and coaching qualities
Must have exceptional attendance
Must be able to work between the hours of 8AM and 6PM
Microsoft Office experience

233

Quality Assurance Specialist Resume Examples & Samples

Bachelor’s degree or equivalent combination of education and/or experience
10 or more years HMO claims processing experience in a managed care environment, preferably PMG/IPA setting within the last seven years or any combination of education and/or experience which produces an equivalency
Comprehensive knowledge on claims reimbursement methodologies, data elements and coding
Strong knowledge of HMO membership, plan benefits, plan designs and health plans protocols on enrollment in a managed care environment
Extensive knowledge of medical terminology, HMO claims processing guidelines including EDI Claims, and government claim processing regulations
Knowledge of AB 1455 Provider Dispute Resolution Mechanism and its application according ICE guidelines
Proficient with producing reports via Access and Excel, data analysis and ability make mathematical calculations
Must possess excellent oral and written communication skills and computer skills. Proficient use of Microsoft Word, Excel, Access, Outlook, and PowerPoint
Must display a high level of flexibility and attention to detail
Must possess excellent customer service and communication skills, be organized and a self-starter

234

Quality Assurance Specialist Resume Examples & Samples

Leads the Complaint Handling team
Recommends to management improvements in the complaint handling process. Works with other functions, as needed, to implement the identified improvements
Interfaces with other departments to resolve customer complaints
Examines pertinent information to determine accuracy of customer complaint and to determine responsibility for errors
Notifies Supervisor of findings, adjustments, and recommendations such as various other testing that may assist in problem resolution or issues not mentioned in complaint that may be contributing to the event
Recommends to management improvements in product, packaging, shipping methods, service, or procedures to prevent future complaints of similar nature
Examines merchandise to determine accuracy of complaint. Performing testing for complaint products as required per procedure
Responsible for planning and conducting internal audits of the Kerr Quality System activities
Responsible for initiating, monitoring, and managing the Kerr Quality System CAPA activities
Assist with QS regulatory compliance activities including external audits
Assist Supervisor with regular QS compliance activities including Adverse Event Reporting, Health Hazard Evaluations, and Field Corrective Actions
Assist Supervisor with regular QS maintenance activities
Ensures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, Canadian Medical Device and other regulatory and/or national and international standards as applicable are continuously met
Maintain CAPA and Internal Audit quality systems compliant with all applicable regulatory standards as above and other relevant requirements throughout the facility
Identify and oversee Corrective and Preventive Action teams in response to concerns identified through complaints, nonconforming materials, audits or other Quality Systems as required
Prepare reports, trend analyses, memoranda and other communications for and on behalf of management as required
Knowledge of the FDA’s Quality Systems Regulations (QSR), ISO 13485 and the EU’s Medical device Directive (MDD)
Participative experience in quality system audits
Knowledge of Quality Assurance/Quality Management Systems
Abilities and skills in leading & organization
Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases
Must be knowledgeable in the proper handling of chemicals and waste, both hazardous and nonhazardous, as defined by FDA, OSHA, EPA and DOT
Bachelor Degree or equivalent in Science Discipline
5-7 years of experience in the medical device industry working with quality system management

235

Quality Assurance Specialist Resume Examples & Samples

Provides administrative support to maintain required certifications and/or accreditations, and compliance to current regulations applying to the laboratories
Performs internal audits, writes and reviews audit reports
Update metrics and databases as assigned
Provide, present and participate in training programs as required
Assists with document control process
Assists with hosting external audits
Assists with exceptions, CAPA activities, and lab investigations
Perform review, revision and signing of test methods, procedures, and lab reports
Two years relevant laboratory/quality assurance experience in a regulated lab environment, with preference for GLP or cGMP

236

Quality Assurance Specialist Resume Examples & Samples

Provide continuous call evaluation feedback to retirement consultants/retirement advisors through written evaluations and review with their managers. Document and escalate call monitoring issues to management as necessary
Evaluate retirement consultant/retirement advisors calls using the quality monitoring data management system to compile and track performance at an individual level
Extract and organize metrics to create month-end reporting and analysis on call monitoring results for internal quality reports, including the following: facilitate call calibration exercises to validate that calls are monitored consistently among the Technical Quality Assurance Specialists, formally update the Operating Committee regarding call monitoring trends and observations
Partner with internal resources (Compliance, Legal, RISK, RSG LOD) to ensure training, resources and feedback includes thorough and accurate information; identify performance gap trends, conduct need/skill gap analysis, contribute to appropriate learning solutions and documentation support
Review and update call evaluation methodologies based on industry and/or internal process changes
Participate in various projects by assisting with organization of training related projects, which includes developing training materials, attending meetings, facilitating training for new hires as it relates to call evaluation methodology or other topics as necessary
FINRA Series 7 & other industry specific registrations/licenses required within GWRS established timelines
Bachelors Degree in Finance or Accounting
Minimum 7 years work experience
Experience working on sales-related financial analysis a plus
Working knowledge of retirement plan products preferred
Intermediate to Advanced modeling/forecasting skills using Excel
Sound reasoning and critical thinking

237

Quality Assurance Specialist Resume Examples & Samples

Operate in full compliance with internal policies and procedures as well as applicable regulations and laws, including but not limited to Scotia’s Anti-Money Laundering alert management requirements
Conducts both regularly scheduled and ad hoc reviews to assess FIU employees’ completed work to ensuring that the review/investigation/analysis are
Excellent communication and interpersonal skills to identify and effectively communicate (oral and written) opportunities for improvement
Knowledge of bank operations and related regulatory requirements, especially in assigned area(s)
Sound understanding of Correspondent Banking, Corporate Banking, Commercial and Small business banking, Retail Banking, Global Banking, Global Transaction Banking products, Wealth Management and Private Banking activity and practices
Working knowledge of the Proceeds of Crime Money Laundering and Terrorist Financing Act (PCMLTF) and supporting regulations, Office of the Superintendent of Financial Institutions requirements (OSFI), Financial Action Task Force (FATF), the Wolfsberg Group principles and the United States Patriot Act
Solid knowledge of the Anti-Money Laundering and Know Your Customer policies and procedures
Proficiency with AML/ATF systems/platforms and common computer applications (Word, Excel, Lotus Notes, PowerPoint and internet search engines)
Strong critical thinking and analytical skills to rational and logical deductions at times with limited information
Ability to gather, analyze, organize, document and present large volumes of information in succinct and organized manner

238

Quality Assurance Specialist Resume Examples & Samples

Bachelors degree in Medical Laboratory Science OR Bachelors degree in Nursing; other applicable Bachelor degree programs may be considered
Knowledge of hospital and / or laboratory accreditation which may include: Clinical Laboratory Improvement Act (CLIA), Foundation for Accreditations of Cellular Therapy (FACT)
Minimum 3-5 years Clinical Laboratory Experience OR BMT RN experience OR experience in laboratory or clinical Quality Management
Experience in research and accreditation
Experience in creating policies, standard operating procedures

239

Quality Assurance Specialist Resume Examples & Samples

Enter incoming audits/CAPs into Access database
Sort/distribute mail; scan documents for archives and regulatory purposes
Answer phone calls; make follow-up phone calls
Assist in scheduling and coordination of meetings
Generate letters and correspondence
Works independently
Acts as a resource for others

240

Quality Assurance Specialist Resume Examples & Samples

60% Monitors and compares samplings of inbound & outbound customer interactions to defined standards for accuracy, adherence and customer service. Uses this data to also identify trending in call types, call drivers and operational process adherence. Identifies and implements solutions and ensures that processes meet company and customer expectations
20% Provides constructive written and verbal feedback to customer service agents on required performance improvements. Provides feedback to the management team and training department on opportunity areas. Prepares quality reports for management review
10% Routinely conducts and participates in calibration sessions with three distinct audiences in order to ensure that service levels and operational processes are consistent across the total business
10% Partners with the training department to support the creation and delivery of Q/A specific training content and initiatives

241

Quality Assurance Specialist Resume Examples & Samples

Responsible for participating in investigation meetings with responsible department and any required support group(s)
On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide quality assessment of potential deviation
Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues
Execute training/awareness related to investigation and GMP changes to production personnel
As appropriate to area of responsibility, responsible for ensuring sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner

242

Quality Assurance Specialist Resume Examples & Samples

Work with stakeholders to understand key campaign parameters and inputs, such as subscriber audience, program frequency, degree of personalization, and overall creative approach
Develop appropriate, campaign-specific testing approaches
Perform functional testing of emails (clicking links, confirming tracking data, etc.) to confirm accuracy based on stakeholder requirements
Review key aspects of the email design, build, and deployment processes to ensure optimal quality, including

243

Quality Assurance Specialist Resume Examples & Samples

Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls
Perform reviews of deviations and investigations, equipment, process and method validations as well as of executed batch records
Maintains sufficient expertise in one or more QA disciplines to independently perform analysis and draw appropriate conclusions. Communicates with manager and other stakeholders (internal and external) to ensure communication of outcomes
Responsible for leading departmental projects for process improvement and other projects as assigned by their manager
Responsible for actively participating in group training and coaching efforts. Positively influences peers in achieving operational and project initiatives and objectives. Is a recognized technical and procedural resource for peers
Proactively monitors discipline of expertise for issues. Initiates solutions and preventative actions
Maintain Master Batch Records and provide support for regulatory filings and change controls
Provide support for regulatory inspections and GMP audits
Responsible for engaging in regular contact with external organizations. Acts as liaison with new vendors and independently resolves issues with vendors
Responsible for independent technical and non-technical troubleshooting. Serves as a representative to cross functional troubleshooting teams
Identifies and resolves basic technical issues using problem-solving skills, in consultation with Manager
Independently revises department-specific controlled documents
Responsible for independent decision making and routine issue resolution. Keeps Supervisor informed of activities and issues
Participates in required training and keeps training files current
Independently performs assigned tasks in the design and implementation of departmental process changes and other projects as assigned
Able to identify complex problems and consistently propose solutions. Reviews goals and plan regularly and realign priorities consistent with organizational shifts. Continually seeks creative process improvements
Actively integrates big picture understanding into all interactions. Drives team cooperation and credibility focusing on positive results. Encourages communication, cooperation and win/win solutions
Responsible for coordinating activities to administer assigned tasks. May coordinate activities cross functionally
Influences others to focus on goal attainment by actively generating solutions to wide range of challenges
Performs additional duties, as assigned
Solid understanding of applicable regulations and guidances. Demonstrates expertise of department processes, tools and methods

244

Quality Assurance Specialist Resume Examples & Samples

Accountable for overall performance and quality of web applications
Evaluate new technology and techniques in order to improve/create cost-effective solutions
Design, write and fulfill test plans and test scripts
Determine nature of testing to be performed and identify tasks that should be manual vs. those that can be automated
Perform integration testing with 3rd party applications
Provide input/status updates regarding test progress/results
Minimum of 3 years as Lead QA Engineer or QA Manager
Demonstrated project and team leadership skills
Experience leading web application test projects from planning to release
Attention to detail and highly organized
Must be flexible and occasionally available after normal business hours to test production releases and other QA testing as needed

245

Quality Assurance Specialist Resume Examples & Samples

Experience with writing test documentation, including test plans, test cases, and requirements traceability matrix
Experience with tailoring a test approach to address resource and schedule limitations
Experience with the DoD or IC preferred
Experience with DevOps, continuous integration, Linux, Docker, OpenShift, Ansible, and AWS
Experience with Universal De-identification Platform (UDiP) and Natural language processing (NLP)
Experience with requirements review
Experience with peer reviews, walkthroughs, inspections, and audits
Experience with continuous integration and deployment
Knowledge of the SDLC and the role of quality in each phase
Ability to collaborate between functional areas, including business analysis, development, and support teams

246

Quality Assurance Specialist Resume Examples & Samples

Monitor, progress and follow up corrective actions and preventative actions
Assess events and their root causes, ensuring appropriate corrective and preventative actions
Participate in root cause investigations
Participate in internal/external audits
Manage the timely disposition of all APIs whilst ensuring OTIF is met

247

Quality Assurance Specialist Resume Examples & Samples

Responsible for quality control for the work of the department
Responsible for weekly and monthly metrics output and continuous improvementactivities
Implements regular audits, documenting and presenting outcomes to leadership

248

Quality Assurance Specialist Resume Examples & Samples

Work closely with QA Technicians Senior and level II in base business related activities to ensure adequate operations support
Support QA Team on a daily basis in related activities deliverables
Works in the different areas of Quality Assurance based on business needs
Supports operational functions, quality, engineering and others to ensure objectives are met
Supports operational functions, quality, engineering and others, as needed, in the implementation of corrections / corrective actions for identified issues, through the use of quality principles and data
Executes protocols as necessary
Performs tests and data analyses to recommend disposition of material
Responsible for monitoring and reporting QA holds
Responsible for the control and monitoring of the QA hold area
Completes records of inspection results, acceptance, rejection, and disposition of material
Interpret and execute statistical analyses, as needed, including but not limited to FMEA and SPC
Support operational functions, quality assurance among others in continuous improvement activities as they relate to the reduction of product inquiries, efficiencies and or other initiatives
Provide materials/communication or service to customers in a timely manner
Recommends revisions, corrections, and changes to test equipment, procedures, and methods
Provide initiative to the QA organization through continuous improvement projects
Provide necessary feedback to customers
Fosters collaborative discussions with business partners regarding quality issues, projects, and activities as required
Support/provide coverage for absences as required
Work cooperatively toward effective outcomes
Work to resolve differences in a collaborative effort
Promote safety to all associates that enter the work area
Attend required safety training
Implement and follow all applicable EMS procedures
Adhere to the site’s EHS Code of Conduct
Two to Four years of experience within manufacturing operations, preferably in the medical device industry
Prior experience in quality assurance, or related area, is preferred
Knowledge of product and process specifications
Knowledge of Good Manufacturing Practices (GMPs) and ISO (International Organization for Standardization) policy and procedures is preferred
Basic computer skills and use of software applications
Requires long periods of walking, standing, bending, stooping, reaching, and sitting
May require lifting of boxes or material not to exceed 50 lbs
May require use of a pallet jack
Standard hours are 8:00pm – 4:30am Monday- Friday, but requires flexibility to work first shift for the first 2 months of training
This position may require up to 5% travel, both international and domestic.4719170314

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Quality Assurance Specialist Resume Examples & Samples

Knowledge of Contractor Performance and Compliance
Skill in Written Communications
Ability to recommend Contract Modifications

250

Quality Assurance Specialist Resume Examples & Samples

Good knowledge in STLC, Defect lifecycle and SQL
Test Automation experience using HP UFT/ QTP
Ability to write and run SQL queries/ DB Testing
Automation Testing experience using HP QTP/ UFT
Knowledge of Test automation framework and hands-on design experience is a plus
Proficient in Test Management Tool; HP Quality Center or MS Test Manager - TFS
3 – 5 yrs

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Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

Quality Assurance Specialist Resume Examples & Samples

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