Specialist QA Resume Samples

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N Green

Napoleon

Green

1722 Monte Trace

Houston

+1 (555) 781 4825

1722 Monte Trace

Houston

Phone

p +1 (555) 781 4825

Experience Experience

San Francisco, CA

Specialist QA

San Francisco, CA

Rippin-Reilly

San Francisco, CA

Specialist QA

Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.)
Provides support and oversight of New Product Introduction (NPI)
Evaluate practices for compliance and operational excellence improvement on a continuous basis
Perform comprehensive Quality review to support lot disposition of bulk drug substance
May support the Network for assigned quality process
Mentor and coach cross functional team members in order to establish a quality culture for routine operations
Provide lot disposition and authorize lots for further processing

Los Angeles, CA

Specialist, QA

Los Angeles, CA

McDermott-Macejkovic

Los Angeles, CA

Specialist, QA

Provide input to the development of personal performance goals and departmental objectives
5%: Works closely with the Manager of QA to develop testing protocols for all TSA product private label products
5%: Works with the Manager of QA to ensure we have a strong Factory Audit Process
Understands and accommodates established process and project timing. Deviates only if provided direction
Collaborate with Management to establish and meet targets and timelines
Generate departmental performance metrics for review by management
Provide assistance to customers in support of departmental functions

present

Phoenix, AZ

Specialist QA Engineer

Phoenix, AZ

Dooley, Dickinson and Jakubowski

present

Phoenix, AZ

Specialist QA Engineer

present

Be involved in new features development, provide inputs to POs and Developers on the correct behavior of the system
Be involved in new features development; provide inputs to POs and Developers on the correct behavior of the system
Be part of a cross functional Scrum team that develops and supports the product. You will be working hand in hand with the other R&D functions
Worked in a product company, performing testing for distributed enterprise product
Adhere to agile development principles while following and improving all aspects of the scrum process
Serve as focal point for all matters quality related and interface with offshore QA management
Define, write and execute effective test cases for both Front and backend

Education Education

Bachelor’s Degree in Science

California State University, Los Angeles

Bachelor’s Degree in Science

Skills Skills

Strong stakeholder management skills able to communicate across delivery teams and business representatives
Excellent understanding of product development in the mobility space
Decision quality
Effective communication skills at multiple levels and areas (inside and outside of Quality)
Throrough decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc
Good competency in developing effective solutions to diverse and complex business problems
Ability to work effectively across different stakeholder groups ranging from business analysts to product managers and developers to discuss Quality Assurance considerations and implications
Systematic, meticulous approach in managing tasks without being lost in the details and focused on overall objectives and timelines
High proficiency in both written and spoken Mandarin
High level written and spoken English communication skills coupled with fluent Mandarin are essential

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15 Specialist QA resume templates

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Software Engineer Specialist QA Resume Examples & Samples

Test Strategy, Test Planning , Test case design, analysis, coding, testing, and integration
Manages and expands relationships with internal and outsourced development partners on design and development. Also to work on arriving at test methodology and testware
Review and feedback to the team on various activities with respect to execution and quality
Provides guidance and mentoring to Team
Minimum 5-8 years’ experience
Good Understanding and working knowledge of hardware , firmware and components
Low-level assembly/C/C++ code testing on microprocessors (Intel, AMD, ARM, DSPs, IBM PowerPC), embedded applications, embedded OS (RTOS, micro-kernels, embedded Linux)
Hardware Abstraction Layer knowledge for any of the above microprocessors, knowledge and working of BIOS / SMBIOS / UEFI / EFI layers for x86 platforms would be preferred
Hands on experience in testing Microprocessor evaluation platforms
Experience in development of FW test bench or work bench & HW test , Debug tools know how would be preferred
Experience in QA function for OS/firmware based components
Working knowledge of OS system level concepts - Windows, Linux
Scripting Perl/Shell/QTP working knowledge
Experience in Leading Test teams/Programs
Good analytical, problem solving & debugging skills
Writing and evaluating forms and processes for testing and methodology, including writing and execution of test plans, debugging, and testing scripts and tools

Software Engineer Specialist QA Resume Examples & Samples

Minimum 6 -10 years experience
Software testing methodology, including writing and execution of test plans, debugging, and testing scripts and tools
Experience with design for software and firmware running on multiple platform types
Software systems testing methodology, including execution of test plans, debugging, and testing scripts and tools

System Software Engineer Specialist QA Resume Examples & Samples

Collaborates and communicates with management, internal, and outsourced development partners regarding test status, project progress, and issue resolution
Experience/good understanding of System Imaging/restoration/virtualization technologies
Test Automation / Scripting knowledge (Python, Selenium desirable)

Bsa Compliance Specialist, QA Cz Resume Examples & Samples

Legal & Regulatory Risk Management. Assesses and mitigates the risks associated with high risk customers through Quality Assurance review and suspicious activity identification throughout M&T Bank Corporation to ensure compliance with Federal and State laws and regulations and to minimize penalties and reputational losses
Legal & Regulatory Identification & Communication. Remains current on legal and regulatory requirements in cooperation with Counsel’s Office, as applicable
Compliance Policies & Control Procedures. Implements internal policies and control procedures with a thorough knowledge and understanding of guidance, laws and regulations. Makes recommendations to improve policies and procedures to maximize departmental resources
Responsible for performing tasks in a manner that are compliant with applicable laws and regulations and / or that serve to help the company be in compliance with laws and regulations that apply to the business line the position supports

Dps-quality Assurance Specialist / QA Resume Examples & Samples

Work with the Client project team to test updates, patches, and repairs to the application software components in the development, test, and QA environments. Develop software changes for promotion to production following best practice and standards as defined by the Client ITO
Take corrective action, subject to the Client Management approval, to resolve all issues and problems encountered with testing to ensure the applications perform as required
Design, execute and maintain automated test scripts
Programming background

Specialist, QA Resume Examples & Samples

Participates as a specialized knowledge resource in established processes
Suggests improvements to business processes and independently completes small sub-projects within a defined course of action
Will organize specialized and defined information for review
Tends to reference documented process and practices and learnings from previous experience to address challenges. May handle more common complex challenges but Escalates situations that have not been encountered previously
Most decisions are based on prescribed and dictated guidelines. Knowledge of theory and practice Will assist with the ability to interpret and determine next course of action that May deviate from the norm
Understands and accommodates established process and project timing. Deviates only if provided direction
Relies on general direction to understand importance and urgency of work content
30%: Works with the 3rd party lab to ensure that all our products are tested to the necessary protocols
15%: Coordinates approval to ship with our freight forwarder and logistics team, based on updating testing results
15%: Works with vendors, agents, and internal departments to complete vendor agreement and set up process
10%: Works with the Manager of QA to ensure the Product Inspection Process is being monitored. Engages the right parties to make final decisions on quality related issues
15%: Reports out on a regular basis the performance in the following areas: Vendor performance – number of failures, quality issues; agent performance – inspection issues; lab performance – on time and accuracy
Responsible for other duties as assigned or developed, master Kit List – save Test Reports, work with PD team on failures, log on MKL, send official 'Ok to Ship' to approved vendors, MTC weekly report for YUSEN and Logistics
5%: Works with the Manager of QA to ensure we have a strong Factory Audit Process
5%: Works closely with the Manager of QA to develop testing protocols for all TSA product private label products
5%: Communicates with key vendors and other 3rd party service providers to ensure they understand our QA processes
Bachelor’s degree in a related field or equivalent relevant experience
Strong proficiency in Word, Excel, PowerPoint and Outlook
Awareness of web technologies, standards, and usability
1-2 years experience with quality assurance or a technically related field
Retail/Manufacturing experience is helpful
Possess strong computer skills in Word and Excel
Good verbal and strong written communication skills
Strong Organizational, follow up and completion skills

Specialist, QA / QC Resume Examples & Samples

Perform QC Inspection of repaired endoscopes in a timely manner to meet customer needs
Follow current SOPs and use current Inspection Forms for all product models
Train new employees in the area on QC Inspection processes as required
Perform tasks and other duties as assigned by the Quality Manager
Highly focused and results-oriented; able to identify goals and priorities and resolve issues in initial stages
Demonstrated ability to work independently and in a close team environment, self starter who can motivate others
Work with a sense of urgency, understand his/her expectations, and always maintain focus on
The changing priorities of the division
Minimum 2 year technical degree with 5 years work experience in a regulated industry
The ability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives is required. Strong collaboration skills will be required
Microsoft Word, Excel, and G-Mail knowledge required
Experience working with endoscopes and related equipment preferred
Ability to read, analyze, and interpret essential job related documents
Ability to communicate (written and verbal) effectively and professionally

Software Test Specialist QA Resume Examples & Samples

Take ownership of software defects from discovery through to closure
Provide Test Summary & Daily Status Reports
Documentation including reviewing Functional Specifications, Test Planning and contributing to Test Specifications for Feature Testing
Communicate with developers, project managers, and management on testing status
Develop automated Functional/Regression testing using Selenium
Work to ensure testing is on schedule and identify and work with QA Manager on issues that are delaying testing
Provide support for Production and UAT phases
Minimum 3 year’s software test experience
Good analysis, problem solving and troubleshooting skills
Comfortable participating in Agile development process
A positive and enthusiastic outlook both within the team and when working alone
Be highly motivated and demonstrate the willingness to learn and to grow within the role
Excellent organizational skills to focus on the tasks at hand
Ability to deliver quality documentation & reports – status reports, test plans, test cases
Experience with IntelliJ, SVN, Confluence, JIRA, Zephyr
Familiarity with Oracle or other RDMBS other databases
Automation experience using Selenium / Web Driver and build / deploy tools (i.e. Jenkins)

Specialist QA Resume Examples & Samples

Thorough knowledge of the processes involved in clinical and commercial manufacturing, warehousing, supply chain, equipment engineering principles and validation
Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 68/01 chapter 2.2 (Responsible Person)
5 years of professional experience in pharmaceutical environment (GMP)
Relevant experience in dealing with Quality systems such as Non Conformances, CAPA’s and Change Control,
Throrough decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc

Senior Specialist, QA Complaints Resume Examples & Samples

Responsible for maintaining compliance with FDA/EU/USDA regulation in the area of product quality complaints. As the primary and initial QA contact for receiving all product quality complaints, this individual will gather all available information from all sources and make an initial assessment of severity of all complaints received
Will initiate, conduct investigation to include batch record, retain, stability sample review etc. and report summary conclusion and findings for every complaint. Will track return samples and coordinate sample testing. Will provide guidance and support to all groups dealing with complaint handling life cycle, complaint related SOP's and Trackwise questions
Incumbent will assist with OOS's and assign investigation, review investigations and summarize the investigation as well as disposition the product in question in a timely manner
Will generate and or improve processes to enhance and maximize resource utilization
Will review related temperature excursions for products shipment and perform appropriate investigations and recommend appropriate disposition
Assign investigations and CAPAs to logistics and impacted departments and follow up on the CAPAs
Assist with trend analysis and report the analysis to management as appropriate and monthly KPI tracking for complaints
Provide input to improve processes to enhance and maximize resource utilization
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management
Work experience in FDA, USDA or European Union (EU) regulated animal health industry required

Specialist, QA Batch Release Resume Examples & Samples

Coordinate, review and perform release of all Finished Products for External Manufacturing
Administer the GMP documentation program to support the operational and compliance needs of the organization
Approve labeling changes and generation specifications
5-8 years of experience in the pharmaceutical industry with a minimum of 5 years in Quality Assurance

Lead Specialist, QA Investigation Systems Resume Examples & Samples

Review investigation reports in order to ensure that appropriate steps have been taken throughout the investigation and that all information regarding the investigation are accurately and correctly documented
Conduct quality review of all levels of manufacturing investigations. Lead Specialist will focus mainly on review of Major and Critical manufacturing investigations
Responsible for attending and representing Quality Investigations in more high level meetings than required of a Sr. Specialist. Meetings in support of product transfers, new product launches and batch viability as result of Major and Critical events
Revise and review Standard Operating Procedures associated with the Manufacturing Investigation System
Provide training to personnel on appropriately documenting IRs. Additionally, a Lead Specialist will be expected to mentor and provide guidance to Sr. Specialists within the group
Review and approve Notice of Rejections (NOR) and develop TrackWise Reports for site as needed. Ensure associated batch records are documented correctly
Lead Specialist will be responsible for managing any projects or areas of responsibilities as directed by departmental Management. These may include but are not limited to; managing investigations in support of site Launch products, managing communications to Mylan Affiliates in regards to product manufactured for outside markets as well as coordinate 3rd party investigation activities as needed
Coordinate and lead meetings dialing with Investigations, CAPAs or process improvement strategies during the course and closure of investigation reports as well as taking on CAPA plan reviews and approvals when needed
Lead Specialist is expected to make independent Quality minded recommendations to Senior Quality Management on high risk / high impact events
Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience, preferably within the Investigation Group. However, a combination of experience and/or education will be taken into consideration
Must possess knowledge of and adhere to Company and departmental policies and procedures, as well as government regulations. A knowledge of pharmaceutical manufacturing is desirable. Knowledge of the FDA regulations is required
Must possess good written and oral communication skills, interpersonal skills, and a working knowledge of Microsoft Word and Excel
Ability to solve practical problems through standardized solutions that require limited judgment. Ability to follow prescribed and detailed procedures to solve routine problems. Ability to utilize Root Cause Analysis Tools as well as other Investigation problem solving techniques
Typically sitting at a desk or table. Intermittently sitting, standing or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements
Normal office situation. Works alone or closely with others. Regular exposure to moving machinery and/or vehicles. Regular exposure to chemicals, solvents, fumes and/or gases

Specialist, QA Resume Examples & Samples

Follow company policies and procedures
Collaborate with Management to establish and meet targets and timelines
Independently manage competing priorities with limited instruction
Serve as a Quality representative on cross-functional and multi-site teams
Identify and recommend solutions to potential procedure, process and system gaps
Participate in the design and implementation of department and cross-functional initiatives
Apply basic theory and technical principles to address moderately complex problems
Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
Serve as a technical subject matter expert (SME) in support of department functions
Sign documents for activities as authorized and described by company policies, procedures and job descriptions
Perform tasks as requested by Management to support Quality oversight activities
Review and approve change requests
Assist with discrepancy investigations
Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval
Assist with manufacturing facility and equipment start-up/changeover/tooling activities
Administer the change control and discrepancy management programs, ensuring that each program is consistent with current regulatory and industry guidelines
Provide Quality oversight to internal and external customers
Collaborate with departments to ensure that all review activities are executed efficiently and effectively
Generate departmental performance metrics for review by management

Senior Specialist, QA Resume Examples & Samples

Assist in the establishment of a QA-controlled document system
Organizes and ensure accurate system for the repository of paper-based records as well as the electronic files on the shared drive, and database to track documents
Ensure all GXP documents meet Quality Manual, company's procedures and applicable regulations
Coordinate the revision, review and approval of SOPs ad other GXP documents as required
Ensure timely processing of controlled document change requests, notify employees of revised documents for training, distributes controlled documents in accordance with QA Document Control procedures
Oversees the document change control process
Processes GXP training records. Sets-up, maintain and update the GXP training files
Prepares GXP documents for off-site storage as required and maintains accurate inventory of logs
Assist in the established of Company Archive system for Development, Clinical and Regulatory Affairs

Junior Product Specialist QA Resume Examples & Samples

Implement the Whole Team Test Approach to Agile development
Assist the team in identifying test cases in all 4 quadrants as described in the Agile Testing quadrants
Identify all test cases to support development of new features prior to development starting
Participate in all phases of test execution and documentation including functional, regression, usability, integration and user acceptance testing
Develop and refine full functional test plans and test case templates, test strategy and estimate workload requirements
Develop and execute Quality Assurance test plans and test cases to thoroughly test the business applications based on the clients’ requirements and the development release documents
Participate in Grooming sessions with Product Owners and Developers to ensure a common understanding on what is required is developed
Communicate test plan status to the QA Manager and Project Manager to promote effective critical path decisions for the release
Automate test cases identified so they can be added to the regression pack
Assist the team with functional expertise and guidance on automation coverage along the critical application path per feature

Specialist, QA DP Resume Examples & Samples

Serve as Quality Assurance SME for Drug Product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all product manufacturing, storage and shipping activities are compliant
Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Product
Works closely with internal cross-functional impacted areas, such as CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
Develop and issue quality metrics pertaining to the process quality activities
Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
Review and approves Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
Responsible for documenting and reporting compliance issues to management
Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug product manufacturing. Minimum of 5-8 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
Ability to provide project leadership and guide successful completion of Quality projects
Risk assessment and risk management
Ability to monitor and report on assigned tasks, goals, and objectives

Specialist QA Resume Examples & Samples

Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, raw materials release, nonconformances, change control and CAPAs) at ASM
Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
Perform comprehensive Quality review to support lot disposition of bulk drug substance
Mentor and coach cross functional team members in order to establish a quality culture for routine operations
Participate in New Product Introduction (NPI) team to ensure robustness of product changeover as well as cross contamination controls are in place
Lead and support site/network driven QA continuous improvement initiatives/activities (e.g. supplier quality, stability program, product quality review, customer complaint investigation)
Escalate significant quality issues to Quality management in a timely manner
Act as delegate to Plant Quality Assurance (PQA) Shift Manager to support business needs

Specialist, QA Operations Resume Examples & Samples

Serves as ‘Quality on the floor’ to assist and support manufacturing staff in detecting and solving compliance errors in real time
Audits GMP areas including during production
Reviews and approves ancillary facility and equipment records in support of GMP operations
Reviews and approves assay qualification, equipment, and stability protocols
Maintains and enhances effectiveness of the Quality System
Performs final approval and release of product for shipment to customers
Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 4 years’ related experience; or
Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 7 years’ related experience

Specialist QA Analyst Resume Examples & Samples

Write and execute effective automated test plans and test cases
Escalate issues and potential issues to the agile development team and management
Strong experience testing RESTful APIs and Packaged based applications is a must
Solid experience in a Software engineer role or in a test automation role building frameworks for automated tests
Proven experience working within an Iterative/Agile SDLC
Should possess good knowledge in Core JAVA/ Advanced JAVA that can be helpful to understand the coding logic
Should have strong database testing experience
Experience developing Cloud products in a Continuous Integration / Continuous Deployment environment
Experience with Agile Scrum using JIRA
Behavior Driven Development (BDD)
Globalization Standards
Mobile Test Practices (iOS and Android)

Payroll Delivery Specialist / QA / Research Resume Examples & Samples

Bachelor’s degree or equivalent work experience required
CPP certification strongly desired
FPC or CPP certification as a nice to have
3+ years of work experience in a multi-state payroll environment
Able to read and interpret regulatory and legislative updates
Strong subject matter expertise in one of the various systems being used to process a participant payroll issue like PeopleSoft, or SAP
Customer service
Understands fundamentals of Workflow Management and related reports
Strong payroll accounting competency
Strong understanding of internal controls, SOX, and SAS 70 reports
Ability to work under tight deadlines managing multiple tasks
Siebel or Salesforce (ticket tracking system)
PeopleSoft 8.0 and higher Experience a MUST
W2 and W2C Processing
Workday
Understanding and utilization of workflow tools to maximize usage
Proficient in Microsoft Word, Excel, Access, PowerPoint, and Outlook
Ability to navigate and learn multiple systems
Basic understanding of internal controls
Ability to recognize a system defect
Ability to Problem Solve and drive to root cause

Specialist / Senior Specialist, QA Resume Examples & Samples

Assist in the management of the vendor change notification program
Assist in the management of the Supplier Corrective Action (SCAR) program
Review and approve supplier investigation reports/corrective action reports
Perform vendor audits as needed
Manage Approved Vendor List, vendor quality agreements and surveys
Perform any other tasks as requested by Management to support Quality oversight activities
Technical Duties/Responsibilities
Initiation and review of controlled documents relating to vendor management processes
Review and approve vendor change notifications
Review and approve supplier corrective action reports
Review Raw Material Specifications
Assist with vendor related discrepancy investigations
Generate vendor related performance metrics for review by management
B.A. or B.S. degree (preferably in Life Science) and at least two years experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience
Knowledge of cGMPs or equivalent regulations strongly preferred
Ability to interpret Quality standards for implementation
Ability to independently evaluate situations and propose potential solutions
Ability to communicate clearly and professionally both in writing and verbally
Flexibility in problem solving and work hours to meet business objectives

Specialist QA Resume Examples & Samples

Manage the quality of raw material suppliers to ensure Amgen’s requirements are met, changes and issues are addressed, and a cycle of continuous improvement is driven between Amgen and the suppliers
Negotiate quality agreements with suppliers and corporate functions as required, pertaining to the area of Supplier or Contractor Quality Management
Own specifications, non-conformance records, CAPA records and change control records
Manage Raw Material reserve samples
Compile and report key departmental metrics
Support Lean Transformation and Operational Excellence initiatives
Provide Quality support for non-conformances (NCs), Change Controls and CAPA records; ensuring scope of record is clear and implementation activities are robust and timely
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies
Provide Subject Matter Expertise for quality critical components
Introduce new techniques to QA Incoming, including method transfers, reports, validations and protocols
Evaluate practices for compliance and operational excellence improvement on a continuous basis
Disposition of raw material and components
University degree gained in Chemistry, Biology or Science related discipline
Significant experience gained within the pharmaceutical or biotechnology industry or other relevant experience that may be deemed suitable
Understanding/experience with NC/CAPA system, Change Control Management System, Documentation Systems and SAP/Inventory Management system
Knowledge of applicable Regulatory requirements & standards

Senior Specialist QA-quality Risk Management Resume Examples & Samples

Lead Internal Audits and Walkthrough Audits
Lead process improvement initiatives
Support of Supplier, Deviation, Change Control, Complaint and Record Management
Tracks and monitors local operational and quality performance
Escalates issues to the Quality Systems CoE Associate Director as appropriate
Ideally 3+ years experience in Quality, Technical Operations, related Business Operations or GMP regulated environment with regards to Quality Risk Management and Sterile Manufacturing of Biologics
Experience in Auditing and Supplier Management
Demonstrated problem-solving skills, preferably Six Sigma Tools
Ability to work within a matrix organization and leverage expertise from other MSD functions and departments
Proven self-starter
Possesses excellent interpersonal, inclusion, and communication skills
Appreciates and respects diversity, cultures, and norms in a team
Works independently within Quality
Drives results
Escalation of issues / concerns to management, as appropriate
Ability to prioritize, align and simplify
The candidate should be fluent in German and English

Specialist QA Resume Examples & Samples

8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
Direct experience with bulk manufacturing of biopharmaceuticals preferred
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

Specialist, QA Compliance Resume Examples & Samples

Assists with planning, scheduling, and maintaining the internal audit program at the site, with the approval of this individual’s management
Establishing and adhering to the internal audit schedule on an annual basis
Documents and reports on findings, recommendations and agreed-upon corrective actions
Participates in external audits and inspections
Preparing and submitting reports and providing information by required deadlines
The review of the previous audit report, work papers and implementation status of the findings and recommendations
Assists in presentation of findings and report preparation
Training other Compliance Specialists on general cGMP Quality System regulations and international standards
Training other Compliance Specialists on proper standards and practices of effective auditing
Conduct follow-up audits when necessary to non-compliance issues
Pre Audit planning and preparations
Discussions with site management, departmental management, and departmental personnel involved in the specific areas of their assignments
Development of the audit scope and focus plus assignment of audit team responsibilities during the audit
Recommends and reaches agreement on corrective actions
Performs all other tasks as assigned
Demonstrates proficiency in applying audit principles, skills and techniques
Intermediate knowledge of cGMP regulations. Familiarity with ICH quality structure a plus
Intermediate knowledge of PC based office computers and standard Microsoft Office applications
Basic knowledge of electronic document and data management systems
Ability to demonstrate controlled gowning
4 years’ relevant work experience required
ASQ Certified Quality Auditor (CQA) or equivalent certification required
An equivalent combination of education and experience may substitute

Specialist, QA Change Control Resume Examples & Samples

Oversees the Change Control administration system (number assignment, typing, file maintenance, electronic file maintenance, and distribution)
Facilitate and coordinate with Document Control customers in getting GMP documents revised, processed and approved. Ensure Change Controls are routed in a timely manner
Maintains an effective change control system. Re-engineers the current system into a more efficient, user friendly system
Organizes and maintains records of Change Control Board meetings
Writes, reviews, approves company GMP-related policies and SOPs
Develops new approaches to solve problems identified and recommends steps for improvement
Performs special projects assigned by QA management
Keeps abreast of cGMPs and working knowledge of government and industry quality assurance codes and standards
2-5 years work experience in manufacturing environment required
Excellent English grammar and writing skills are required for success in writing SOP’s, reports, memos, proposals, etc. required
Excellent computers/software skills such as: Word, Excel, Access, PowerPoint, Outlook, etc. required
Knowledge and experience in a GMPs regulated industry is highly preferred; candidates with experience in other “regulated” industries may be considered preferred

Product Specialist QA Resume Examples & Samples

Coordination and development of test cases
Analysis and control of test cases
Understand business processes and validate if our product matches business requirements
Must possess a college degree or equivalent work experience
With a technical background has already developed first quality testing know-how
With business experience: CP, PM/CS, track & trace, logistics or others
Has gained first experience with common testing tools such as TestLink and Jira
Has experience in writing technical documentation, preferably using Confluence
Proven ability of fast learning and independent and structured way of working
With the aid of best practices and eye for detail lays a strong focus on quality
Preferably has made some first experience with XML or HTML
Willingness to work in a small team and to work in a company setting where flexibility is both given and asked for

Specialist, QA Resume Examples & Samples

Support day-to-day Quality Assurance activities in accordance with approved SOPs /
Policies for a large scale, multi-product, GMP biotech contract manufacturing facility
Able to take on role of QA Specialist in one of 4 areas: Quality Systems, QA Engineering, QA SCM/QC or Quality Operations
Displays a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience
Able to detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections
Ability to participate in walkdowns and begin to provide usable feedback
Generally provides basic compliance support to staff in all departments
Demonstrates appropriate interpersonal skills which encourage collaboration of individuals or teams to meet objectives
Any other tasks as and when assigned by supervisor
Diploma with 1 to 2 years’ experience in a similar type of industry or a similar job role
Degree from recognized institution

Specialist, QA Lot Release Resume Examples & Samples

Receive, review, scan and archive executed manufacturing batch records per QA SOPs
Review EBS based executed production batch record
Evaluation of appropriate GMP documentation such as filter integrity tests and QC data
Create PDF format files of all reviewed batch records for electronic archiving and maintains the public access database for reviewed PDF batch record copies
Verify deviation closure in TrackWise and QC sample results in LIMS
Prepare and assemble Purification or Cell Culture Batch Records Lot History Files and Supplemental Files for FBDS lot release
Responsible for generation of Bulk Lot History Genealogies
Maintain and update QALR Databases for batch record review status
Responsible for the preparation of Bulk release package and bulk pooling
Documentation, including preparation of the Certificate of Compliance For Further Processing (C of CFP) and Regional Certificate of Analysis (C of A)
Provide Manufacturing dates to QC for preparation of C of A
Provide documentation to EQA, MFG, QC, Validation, RA and QC Raw Materials as requested
Receive, scan and archive supplemental cGMP documentation (Custody Transfer documents, Interim Releases, C of A, C of C)
Responsible for reviewing OBM electronic batch record review
Attend bi-weekly QALR staff meetings
Attend weekly MFG batch record exchange meetings
Work closely with Manufacturing Manufacturing Supervisors to resolve batch record corrections
Participate with Regulatory inspections as needed
Stay current with Compliance Wire electronic training system

Senior Specialist, QA CMO Resume Examples & Samples

Create and route product specification documents, following MAA/BLA/CTA/IND/IMPD filings provided by Regulatory Affairs, in BioMarin’s controlled document system
Coordinate Trackwise Change Control workflows for review and approval of all product specifications
Track and ensure document implementation timelines
Communicate directly with BioMarin Regulatory Affairs to ensure all regulatory agency marketing authorizations/clinical trial applications mandated changes are incorporated product specifications
Communicate directly with BioMarin Quality Control to ensure Core product specifications include the appropriate sample and temperature requirements
Ensure Certificate of Analysis templates conform to approved marketing authorizations/clinical trial applications
Generate custom Certificate of Analysis to support new jurisdiction applications, as required
Manage product specification item numbers, issuing item numbers to regional specifications and implementing new core item numbers to the appropriate specifications issued from Oracle EBS
Notify all stakeholders of newly published specification documents
Ensure all individual training and group-specific guidelines are kept current
Minimum of 3 years of experience
Strong attention to detail and communication skills required
Ability to maintain organization of a large volume of data in a systematic manner
Experience with cGMP documents
Experience with Regulatory filing content preferred
Experience with EQMS systems (such as Trackwise) and EDMS preferred
Bilingual or trilingual a plus!

Specialist, QA CMO Resume Examples & Samples

Review shipment temperature data to issue Certificates of Compliance, Certificates of Compliance for Further Processing, and temperature approvals for timely drug release
Provide Supply Chain oversight and manage shipment-related deviation lifecycle
Provide oversight of temperature review and temperature excursion SOPs
Transact approved lots within Oracle EBS
Track ID samples through LabWare LIMS, for use in ID and product stability testing
Contribute group release data to commercial and clinical lot release trackers
Monitor TrackWise PRs (Quality Events, Deviations, Change Requests, and CAPAs) and follow-up with individuals weekly to progress records ensuring timely closures
Regularly extract data from TrackWise for generation of QA CMO metrics
Scan, organize, and archive released records for electronic storage on Office365
Manage storage and archival of physical batch records
Perform Cycle Counts weekly for backlog and work completed
Perform gap analysis on Quality Technical Agreements (QTA) and publish/retire finished documents using the internal electronic document management system (EDMS)
Create and route product specification documents, following MAA/BLA/CTA/IND/IMPD filings provided by Regulatory Affairs
Open and set-up Change Requests records for product specification documents
Create manual Certificates of Analysis, as needed
Manage and maintain the CMO Scorecard process
Assist with regulatory and internal inspections, as needed
0 - 2 years of experience
Strong organizational and communication skills required
Proficiency with computer systems – Microsoft Office Suite
2 years of experience in a QA/Compliance/Regulatory setting
Proficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365

Senior Specialist QA Resume Examples & Samples

8 years of professional experience in pharmaceutical environment (GMP)
Relevant experience in dealing with Quality systems such as Non Conformances, CAPA’s, Change Control, Complaints, Internal and External audits
Relevant experience related to interaction with regulatory bodies, including but not limited to for example IGZ, EMA, FDA, etc
Effective communication skills at multiple levels and areas (inside and outside of Quality)
Throrough decision making skills and ability to apply risk based approach
Familiar with risk management tools such as FMEA, etc

Specialist QA for CQC Resume Examples & Samples

2-5 years experience in pharmaceutical environment
Experience in FDA/EU/WHO inspection
Quality Control experience

Senior Specialist QA Transveral Validation & Product Transfer Resume Examples & Samples

Strong interpersonal management skills with demonstrated engaging, empowering and decisive leadership style and well developed relation building skills to gain trust and credibility and to build a great place to work and good social climate
Very good level of written and spoken English and French
Ability to work in a wide and highly complex environment (TRD, Commercial production, QA)
High flexibility and ability to work on the transfer of a high variety of production processes at different development phases
Is able to adapt adequately the quality and validation requirements to the product development phases
Ability to work in an international environment (Transfer to international site)
Simplification and efficiency mindset
GMP requirements for PVDS
Validation requirements for PVDS
QA Validation for validation linked to the product
Quality compliance of the Product Transfer Process
Organizes and provides QA oversight for all product transfer, including product related validations, during the whole product development process, from early phases to commercial production
Ensures a continuous Quality and Compliance improvement mindset within the Product Transfer

Specialist QA Technical Services Resume Examples & Samples

Engineer (Biochemist, Chemist or Electromechanical) or Pharmacist
2-3 years’ experience in an industrial environment
Good knowledge of English (including technical terms related to Maintenance and/or Metrology)
Ability to make sound business decisions using facts and good judgment
Provide QA support to ensure critical equipment in MPU PS/MMC building meet current regulatory and GSK Vaccines design standards
Provide QA expertise (regarding technical issues) during regulatory inspections impacting MPU PS/MMC
Drive a continuous Quality and Compliance improvement mindset within the TS department of MPU PS/MMC
Insure adequate QA oversight over the Technical Services department (which includes Engineering, Maintenance, and Metrology activities) for the MPU PS/MMC

Senior Specialist QA Engineer Resume Examples & Samples

Setting up and installing various testing environments, with focus on data driven testing, including end-to-end large-scale data driven analytics testing
Planning, performing and reporting on testing for different environments according to technical design and functional requirements
Intoruce automation to QA processes to ensure assimilation of regression testing
Interface with the various R&D, Product Management, and analytics & data science team-members locally and in other global locations Interface with the various R&D, Product Management, and analytics & data science team-members locally and in other global locations
Interface with the various R&D, Product Management, and analytics & data science team-members locally and in other global locations
Reproduce issues with test data, and verify defect resolutions
E/ B.Tech in Computer Science, Industrial/Electronic Engineering and/or practical relevant experience/knowledge
Experience with data driven testing, including using large-scale data
Experience with analytics applications – machine learning and big data platforms
Experience with mathematical algorithms
Very strong verbal and written English skills

Specialist QA Engineer Resume Examples & Samples

Be part of a cross functional Scrum team that develops and supports the product. You will be working hand in hand with the other R&D functions
Build automation test suits for regression and new features. Testing UI components, Web Services, Checking data in databases, automating deployment and data generation
Open bugs detailing relevant information in a repeatable way
Be involved in new features development, provide inputs to POs and Developers on the correct behavior of the system
Interact closely with Build Engineers on the evolution of Continuous Integration and Deployment
B.E./B.Tech in Computer Science, Industrial/Electronic Engineering
7+ years of experience in IT as Developer, Automation engineer or QA
2+ years of experience in UI automation testing
Experienced working with Databases, writing SQL queries for data validation
Experienced with defect management and tracking tools, preferably Jira
Experienced working on Windows and Linux and/or Unix
Experience working in Agile
A team player

Specialist QA Engineer Resume Examples & Samples

Lead and oversee the QA to ensure proper balance of functional and automation
Building and executing test suites for distributed product deployment
Installation and staging of product deployments in a variety of configurations to testing environments
Reproduce issues, and verify defect resolutions
6+ years of experience in IT as Developer, Automation engineer or QA
4+ years of experience in testing distributed systems with web based front end and backend web services
Worked in a product company, performing testing for distributed enterprise product
Experienced with XML
Experienced working on Linux and/or Unix
Experience with Selenium or Silk4J is a plus

Specialist QA Technical Services Resume Examples & Samples

Provide QA support to ensure critical equipment in MPU HAV building meet current regulatory and GSK Vaccines design standards
Drive a continuous Quality and Compliance improvement mindset within the TS department of MPU HAV
Insure adequate QA oversight over the Technical Services department (which includes Engineering, Maintenance, and Metrology activities) for the Manufacturing Performance Unit Hepatitis A (HAV)

Specialist QA Resume Examples & Samples

Educational Background in Biotechnology, Microbiology or Chemistry, Pharmacy
Strong negotiating and leadership skills
Ability to work within a matrix team environment
Able to operate in a fast paced, dynamic environment
Good communicator to site management, Global Teams and within Regulatory Affairs-CMC (Global and Regional) teams
Manage and execute RA-CMC activities to meet agreed upon timelines

Training Specialist, QA Compliance Resume Examples & Samples

Develop and deliver site level GMP training for new employees and re-fresher trainings as required
Evolve the current system to a world class training program that provides a highly effective and safe workforce focused on continuous improvement
Develop and implement a standardized training process that complies with all regulatory/corporate requirements (GMP focus) by working with site functional leads, Corporate QA, and training peers to develop processes, tools and templates to deliver a standardized approach
Collaborate with external resources outside of the department to analyze the needs and measures for the effectiveness of training
Continuously improve skills and knowledge to maintain alignment with current learning and development trends
Develop, maintain and report appropriate training metrics
Administer the site Training System; ensuring GMP personnel are appropriately and adequately trained to perform their assigned function to a high level of competence, regulatory compliance and efficiency
Act as the Training System ‘expert’ for all day-to-day issues concerning Training and Development
Coordinates quality assurance activities and provide applicable technical assistance and training to personnel
Assign Computer Based Training modules and track completion
Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding, such as “On the Job Training”, quizzes or qualifications
Assign training in LMS according to job roles
Assign SOPs to new hires according to job roles
Prepare and communicate monthly training metrics
Set up offerings for Instructor led training in LMS
Create and maintain departmental curriculums / matrices
Maintain system to track required training and qualifications
Assist with audits (i.e. regulatory, internal) by ensure the timely and accurate retrieval of personnel training and qualifications
Perform compliance self- audits as required
Participate and lead process improvement projects
Provide strategic oversight of the training program and system
Schedule other required training (GMP, Technical, etc.)
Coordinate projects, tasks and personnel to effectively meet with project timelines
Work directly with all levels and departments to establish training curriculum and assignments based on assigned functions
Work with applicable functions to assist in the development of quizzes and qualifications
Liaison to Document Control and other functional departments in coordination of required training
Leads site in all required GMP training
Able to build, contribute to, and deliver training modules
Ability to interact with a diverse group of individuals
Strong verbal and written communication, effective time management, and organizational skills
Must be independent, and detailed oriented
Ability to quickly learn and navigate new electronic systems (MS Office, e-training systems, SAP)
Ability to comfortably speak in front of audiences
Ability to work in fast paced environment supporting the quality assurance/quality control departments

Senior Specialist QA Sterility Assurance Resume Examples & Samples

Master degree in Sciences or equivalent experience: Agronomist, Pharmacist, Biologist, Biochemical engineer, … (Preference for a Microbiologist)
At least 5 years of professional experience in the pharmaceutical environment on site manufacturing sterile drugs or vaccines
Specific operational experience on cleaning of equipment, Bioburden or endotoxin at different manufacturing steps and in sterilizing filtration
Lean and Six Sigma knowledge is an advantage (a.e. Greenbelt certification)
Good Interpersonal skills with demonstrated engaging and decisive leadership style and well developed relation building skills to gain trust and credibility
Very good knowledge of cGMP for biological products
Ability to make a good balance between GMP requirements and manufacturing reality
Strong analytical and problem solving (trouble shooting) skills and flexible thinking capability
Continuous improvement focus – ability to challenge the status quo
Effective communication skills, good level of written and spoken French and English
Effective influencing skills – ability to influence at all levels of management
Training and mentoring skills
Develop MPU expertise on cleaning of equipment / endotoxin / bioburden / sterilizing filtration (trainings to risk assessment, support to MPU for the realization of their RA,…)
Support the MPU in the realization of their analyses of bioburden risks at the process steps. Also ensure a minimum of harmonization between the MPU
Take the role of site SME for cleaning of equipment, bioburden / endotoxin and sterilizing filtration by updating the site SOP's related to the subjects; by acting as an expert to answer the questions of the organization, the authorities,…; by defining transversal CAPA for the site; by assuring a minimum homogeneity in the way the subjects are covered/implemented in the different MPU; by informing the MPU and by updating the processes when guidance change. The person will have to use his operational expertise to help to solve the problems of the site
To be the voice of the site for the guidances/QMS updates; for inter-sites meetings, during forums, …
Develop sterility assurance expertise within the MPU by acting as coach/mentor, answering the questions and making live an `sterility assurance network' through the organization
Ensure compliance to local and international standards, cGMP, Regulatory requirements and all GSK Quality Management Systems (QMS) policies and procedures as applicable as well as adherence to the Environmental, Health and Safety rules
Provide quality environment and leadership for change initiatives in the area of expertise which contribute to the overall effective improvement of GSK Vaccines manufacturing and supply
Share and integrates best practices within the GSK Quality, GSK Vaccines and wider GSK Network
Maintain knowledge and experience up to date in the light of technical and scientific progress and changes in quality management and sterility assurance
Represent quality during external regulatory audits in specific area of responsibility as required
Reply to auditors requests during inspections and supports the manufacturing operations during GMP inspections

Specialist QA Local Business Process Management Resume Examples & Samples

Education : Scientific university degree (Pharmacist, Engineer or equivalent) or equivalent experience acquired through professional experience
Review, correct and improve Standard Operating Procedures against their purpose and scope. Assure readability and alignment against reference standards (Policies & processes)
Be the preferred front line contact person during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility
Acts as QMS subject matter expert (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans)
Performs internal and act as external supplier audits
Understands technical/production complex problems and evaluates potential impact on product quality

Specialist / Senior Specialist, QA Release Resume Examples & Samples

Documentation Review/Approvals
Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards
Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP
Resolves major issues that are not defined by SOP
Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release
Performs review and approvals of APHIS Form 2008s against applicable Outlines of Production for submission to the USDA for all serial releases
Performs review and approvals of MBPS/CBRs/international permits for international releases
Creates and revises export documentation as changes occur
Performs review and approvals of change controls as a subject matter expert (SME) in QA Release for routine change controls
Completes change control action items as assigned
Revises existing procedures as changes occur
Deviations/CAPA
Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review
Writes or participates in deviation investigations for determination of appropriate root causes
Performs follow-up on CAPAs for completion
SAP
Performs movement transactions in SAP system of product as needed
Performs usage decisions for batch release in SAP
Performs second check in SAP prior to batch release
Actively participates on project teams as assigned by supervisor
Coordinates and leads projects with supervision
Coordinates and leads projects within group without supervision
Completes all assigned training by target due dates as assigned by BIVI
Completes on the job training for each assigned job task
Cross trains on other job tasks within department
Assists with training other individuals within the department on specific tasks
Performs training other individuals within department per assigned training plans
Assists QA management with the development of training plans within department and trains others
Inspection
Performs 2nd review/release approval of serials/lots
Initiates non-conformance reports for serials/lots that do not meet requirements
Routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements
Regulatory
Demonstrates understanding of regulations for various countries
Audits/Inspections
Participates in internal audits as assigned by management
Serves as an SME for strategy rooms during internal and external audits/inspections
Identifies, creates CAPAs and tracks them through to completion

Specialist QA Compliance & BRO Resume Examples & Samples

At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry
BSc/BA (or equivalent) in Life Sciences or a related discipline
Solid understanding of solid oral dosage form manufacturing/packaging processes and QC testing methods
Excellent written & oral communication skills in both French and English
Good interpersonal and training skills
Knowledge of most common office software

Specialist QA R&T Compliance Resume Examples & Samples

3-5 years in Pharmaceutical industry, with specific experience in a quality or regulatory compliance role (preferably in an FDA approved context) and knowledge of quality systems and vaccines regulations
Release
Assures the QA release of batches at each production step in compliance with GMP requirements including documentation and certificate review
Manages technical/release problems, evaluate potential impact on product quality and ensures and ensures timely escalation of issues
Assures the management of complaints
Act as inter-MPU (manufacturing performance unit) back-up in the area of responsibility as required
Performs trend analysis on different quality systems to support QA operations to further improve the systems and results
Contributes to inter-MPU (manufacturing performance unit) meetings to share and review trending results as to foster continuous improvement and manage risks
Contributes to the quality strategy and the preparation of the Quality Plan for the MPU (manufacturing performance unit), prepares dashboards to communicate performance against objectives
Perform gap analysis of MPU (manufacturing performance unit) processes with c’GMP and GSK Vaccines Belgium Quality management System
Ensures Documentation management within MPU (manufacturing performance unit) is aligned with GSK Vaccines Belgium Documentation System/SOPs and performs compliance check as well as alignment with method of production, process validation and regulatory files prior to procedure approval; ensure all MPU (manufacturing performance unit) master production documentation is in line with validation and regulatory files prior to QA Operation approval
Approves MPU specific GMP training packages for QA, production and support staff the MPU and ensures QA staff are adequately trained/certified and coach QA team through presence on the shop floor
Timely escalates critical non compliance and compliance/quality risks within yhe MPU to management these risks through the risk register process
Ensures MPU files and Core files are aligned with current MPU processes and regulatory requirements
Ensures all changes implemented within the MPU are aligned with GSK Vaccines Belgium change procedures and regulatory requirements (MPU change control approvals)
Organizes and coordinates MPU preparation for internal and external inspections, applies inspection readiness program for the MPU
Prepares internal audit and self-inspection programs for the MPU and ensures they are performed according to schedule
Review MPU regulatory files are adequately reviewed before submission
Drives a continuous Quality and Compliance mindset within the MPU to ensure compliance with cGMP’s and GSK Quality Management Systems as well as Regulatory Intelligence
Knowledge with GxP regulated environment
Technical knowledge of manufacturing, quality and regulatory activities related to biological products
Knowledge of Change Control system
Good interpersonal, communication (including presentation) and influencing skills
High problem solving skills to cope with this complex, constantly evolving, technical regulatory environment and guarantee the quality and regulatory compliance of GSK vaccines
Demonstrated impact and influence : is recognized as QA decision maker by peer departements
Strong quality and results oriented mindset
Fluent in written and oral English
Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks
Ability to create and maintain networks and build relationships transversally across the GSK network
Creative approach to problem solving

Specialist QA Engineer Resume Examples & Samples

Actively participate in meetings related to Agile development methodology such as planning, reviews, retrospectives, and daily status reporting; influence and encourage best practices, quality and mutual accountability
Build automated test suites for continuous integration and delivery including acceptance, performance, regression and new feature testing of UI components, Web services and various applications and systems
Develop and execute a complete test strategy for products and features including verification of functionality, performance, security and scalability. Insure the quality of the product and provide evidence of release readiness
Analyze and decompose a software system and design a complete system test strategy. Continuously streamline and improve the testing life cycle to ensure test planning, execution, and reporting are effective, agile, and coordinated
Analyze testing results to enhance test plans and scenarios. (Including metrics and benchmarks to gauge improvement)
Pro-active investigation/verification of production defects and continuous improvement of regression tests
Mentor and develop engineers at all levels. Involved in hiring great engineers

Health System Specialist QA Pi Resume Examples & Samples

465669800
Job Announcement Number
Occasional travel may be required for training and/or other work related duties
Missions, organizations, programs, and requirements of health care delivery systems
Regulations and standards of various regulatory and credentialing groups; and
Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement
Experience working in an integral role in supporting and improving all hospital-wide operations and initiatives related to Quality Management and Patient Safety through a systematic, comprehensive, data-driven, proactive approach to performance improvement
The incumbent will provide continuous analyses of pertinent data and provide thorough and comprehensive reports detailing areas for improvement, while sharing expert and insightful opinions concerning its application and potential solutions or next steps
Demonstrate experience working with healthcare statistical applications
Working experience in ensuring the accreditation of a health care facility
Assign to and review work of subordinates, train and work effectively with subordinates from a variety of backgrounds and with different levels/areas of training
Accomplish the quality and quantity of work expected within set limits of cost and time.Plan own work and carry out assignments effectively
Communicate with others effectively both orally and in writing, in working out solutions to problems or questions relating to the work
Understand and further management goals as these affect day-to-day work operations
Develop improvements in or design new work methods and procedures
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Specialist QA-product Quality Review Resume Examples & Samples

University degree in sciences : Pharmacist, Bio Engineer, Biologist, Chemist
Good knowledge of cGMP
Good knowledge of spoken and written English
Exposure to inspections is an asset
Ability to work across boundaries, building strong partnership with key stakeholders from other departments (Operations, QC, TLCM, Global Quality, etc)
Review Quality performance of a family of product that is manufactured or modified at the site in order to confirm the product quality and identify product and manufacturing process improvements and hence reducing the number of Quality issues and defects
Responsible to generate PQRs through following steps
Data analysis (identify trends, deviations recurrences, ..)
Draft executive summary with highlights and conclusions
Lead the consolidation meeting with production, operational QA,QA release, QC, TLCM leader
Report highlights and conclusion to management through the appropriate escalation mecanism
Ensure CAPA follow-up
Contribute to the continuous improvement (L1 audit) of the content and process of the Quality reviews to get PQRs used as a Quality management tool
Be able to defend a PQR in front of inspectors
Own PQR-related SOP, WIs.and maintain their life cycle
Deliver training related to PQR process
Coordinate activities of QA technicians related to data extraction and act as coach/mentor for consultants

Specialist QA Resume Examples & Samples

Provides PQA Oversight to a complex and 24/7 continuous Drug Substance operations (AML 6)
Lead and Supports Continuous Improvement initiatives and projects
Provides support and oversight of New Product Introduction (NPI)
Initiate and lead cross functional teams
Strong knowledge in area of expertise
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development
Demonstrate ability to interact with regulatory agencies
Strong word processing, presentation, database and spreadsheet application skills
Strong communication (both written and oral), facilitation and presentation skills
Ability to evaluate compliance issues
Demonstrate the Amgen Values/Leadership Practices

Senior Specialist, QA Systems Resume Examples & Samples

Provides oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements
Maintains and enhances effectiveness of the Quality System, including identification and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Risk Management, and Deviation processes
Accountable for the system performance/continuousimprovement/compliance of deviation system. Presents and answers questions about deviation systems and processes to Catalent Management, regulatory inspectors and customers
Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations
Manages and maintains equipment and controlled document files
Reviews and approves all facility and equipment records in support of GMP operations
Reviews and approves minor investigations, non-conformances deviations, and change controls in TrackWise®
Files and maintains controlled documents
Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of eight years’ related experience; or
Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of ten years’ related experience

CS Specialist QA Resume Examples & Samples

Liaise with the Customer Service teams to learn and implement best practice and to drive customer and performance improvements
Monitor and report on Quality metrics, deep dive and identify trends/root causes
Ability to evaluate data, identify issues, recommend, own and drive performance improvement areas
Liaise with the Projects Team and Training department to ensure new policies/processes are successfully scoped and rolled out with measurable results against key metrics
Assist with compiling, analyzing and driving Repeat Contact improvement initiatives
Provide IT CS Operations with a holistic view of customer performance and identify the levers which will drive improvements
Provide clear insight into performance drivers and the levers which impact performance
Implement and own action plans which drive performance improvements
Demonstrable proficiency of Microsoft Office including Excel, SharePoint, Word and PowerPoint
Previous experience in creation, implementation and maintenance of Customer Service Quality monitoring programs with proven qualitative results
Ability to deep dive/analyze customer related data and draw conclusions leading to improvement initiative recommendations
Excellent planning, organizational and time management skills
Fluent Italian and English language skills (spoken, reading and written)
Minimum of 2-3 years experience in Customer Service area with 1+ years in Quality Assurance role in a contact centre environment
Experience with SQL and HTML formatting is strongly preferred

Senior.specialist QA Resume Examples & Samples

Bachelor's degree in computer science or a related discipline, or equivalent work experience required, advanced degree preferred, 8-10 years of experience in a systems quality environment required, experience in the securities or financial services industry is a plus
Preferred 10+ years of quality assurance lead role involving large data centric project
Having technical experience implementing Selenium and other QA automation tool
Technical programming experience in Java/J2EE, Angular JS
Able to drive functional requirements various regulatory development projects with the Enterprise target Architecture
Must be a self-starter with effective oral and written communication skills
A self-motivated personality, and able to work efficiently by himself/herself, as well as, in a team
Domain knowledge on Banking and Financial & Regulatory Reporting is a plus
Experience working in agile (scrum) development environment

QA Specialist / QA Senior Specialist Resume Examples & Samples

Management of Product Release, Artwork, Complaint and APQR
Product release after GMP document review within defined timeframe
Ensure all the product release complies with local regulation & SOP
Manage Artwork changes without any regulatory incompliance and monitor the process according to the Artwork schedule
Communicate with Global Artwork coordinator and timely shares information with relevant department for the artwork implementation in a timely manner
Product complaint handling and counterfeit management in line with Global complaint management in a timely manner
Ensure customer’s satisfaction in complaints and minimize legal claims
Perform Annual Product Quality Review to evaluate the product quality and quality system of Roche Korea
GMP Quality System Management and Maintenance
Ensure that all the quality standards & local regulations are implemented in all the relevant operating guidelines & SOPs
Deliver the right GxP training in a timely manner and Ensure that planned traning are implemented and personnel qualifications are suitable for the respective operation
Lead Change Management, Discrepancy Management (gDMS), Risk Management and Validation & Qualification as described in SOP
Support 3rd party audit as well as Internal audit as the co-auditor or SME
Manage up to date Pharmaceutical Quality System documents and implement action items as PQS Coordinator or process owner. 
Quality Project Management, Issue Management and Customer Management
Provide continuous improvement in quality through the projects with good compliance to global PQS standards including GMP and local regulations
Ensure effective customer management practices with internal and external stakeholders. 

International Support Specialist QA Resume Examples & Samples

Documents Customer Service flow processes and updates
Administration and updating of the Customer Service (Zendesk) knowledge base
Inserts key information related to clients profiles which includes anything from communications to meetings through on the Customer Relationship Management (CRM)
Perform workstation support functions related to the technical support of the employees and authorized users of the network and resources
Communicate and document issues as they pertain to essential support and
Monitor all open tickets to seek fast resolutions
Review all open tickets for update and resolution on a daily basis
Document, execute, and resolve the customer's issues based upon current service response and resolution times. (Service Level Agreements)
Take appropriate action by notifying responsible parties of any potential bottlenecks, potential service level agreement failures, and breech of Helpdesk service policies and procedures
Accurately escalate tickets by assigning to appropriate groups and following associated protocol
Resolve all owned calls each quarter during initial contact with customer
Use all available resources to resolve each reported problem within the current Service Level Agreement
Understanding of procurement policies and procedures
Serve as the primary guide to ensure that users stay on track to meet their professional goals
Connect with new clients upon acceptance of admission to ensure overall readiness and escalate outstanding matters that would affect their ability to have a smooth and successful start
Assist users in understanding and completing certificates requirements
Assist users with appropriate course registration
Advise users on university policies and procedures, program requirements and related academic matters
Provide comprehensive outreach to users who are at risk of not meeting satisfactory academic progress in courses
Closely monitor users to proactively identify at-risk scenarios and identify opportunities to develop, implement, measure and improve academic success strategies
Bachelor’s Degree in Computer Systems Engineer, Administration, Marketing, Communications or related field
Programing experience or education a must
Fully Bilingual (Spanish/Portuguese or English/Spanish or English/Portuguese)
Innovative and dynamic
Customer Management instincts and abilities
Competitive – likes winning
Strong curiosity and interest for web applications, technology and IT (“geek” state of mind)
Excellent people skills
Pragmatic
Very strong common sense

Senior Specialist, QA Center of Excellence Resume Examples & Samples

Support Quality Goals & Targets in the Organization’s Strategic Plan
Promote Quality Achievement and Performance Improvement across the organization
Identify areas of improvements and initiate discussions within the QA & E team for potential improvements
Lead the operationalization of various Quality Initiatives & Tools
Develop Quality Metrics to measure quality across the SDLC
Collate & Analyze QA metrics data against the defined parameters
Establish & document guidelines & standards to support QA &E processes
Ensure execution of corrective actions and lessons learned
Conduct process training as required to the various teams in the IT Shared Services
Ensure governance and process compliance across all QA & E portfolios
Setup & maintain quality controls and documentation
Set Quality Control compliance objectives and ensure that targets are achieved
Ensure compliance to standards processes, guidelines & templates across portfolio
Conduct periodic audits of testing artifacts to ensure process & quality adherence
Collaborate with the QE&A Portfolio Leads to ensure testing rigors and artifacts suffice the Phase Gating criteria
Prepare audit reports and communicate the findings to the QMO & TMO Sr. Manager
Identify systemic non-compliance with audit practice & standards and provide recommendation to the QMO & TMO Sr. Manager
Monitor & assess vendor performance through gathering of relevant data & statistical reports
Provide periodic performance feedback on the Vendor
Demonstrated strong relationship management skills to create internal stakeholder buy-in for new policies and aligning to exisiting policies
Proficient knowledge and detailed understanding in the areas of Quality Assurance and Software Testing practices, standards and principles
Excellent presentation skills to provide information to executive level management
Excellent English Communication
Knowledge of IT Quality Assurance best practices with proficient knowledge and detailed understanding in the areas of Quality Assurance and Software Testing practices, standards and principles
Attention to Detail, Thoroughness, Dealing with Complexity
A knowledge of statistics is required with general numeracy, coupled with good interpersonal skills. The job function covers all aspects of a work group's or company's operation and requires the ability to assimilate and analyze information
Proficient knowledge and detailed understanding of the software development life cycle and methodologies
Adaptable to set and prioritize work with varying exceptions
Working knowledge and experience in Retail sector preferred
QA hands on experience is an asset but not required
2 + years of work experience in setting up Quality Control & Assurance team with standards, policies and tools
Significant Experience in preparing and monitoring internal procedures for adherence to regulations and policies
Significant Experience in analyzing business processes and identifying methods of improvement
Significant Experience developing operational processes and procedures through a collaborative approach
Significant Experience performing internal audits and preparing formal audit reports along with recommended solutions for improvement

Specialist QA Engineer Resume Examples & Samples

Guide and train the team about Testing Methodologies, Standards, Tools and Practices, Testing Automation
Guide and train the team regarding mapping business scenarios to testing scenarios
Define, Review and Accept TRDs / STDs
Customer Facing - Work closely with Product, Professional Services and Customers regarding testing scenarios, testing data and testing practices
Work closely with other teams in R&D to sync up on the testing practices (as part of the QA Experts community)
Take part and lead Customer Engagement processes – Interact with Actimize Customers on Testing Methodologies and Share test data, scenarios, reports, etc
Degree in computer science/ Engineering or a related discipline (BCA/MCA/BE/ME/M-TECH)
6-9 years of software testing experience in a Test/QA Team with Enterprise Product preferably in financial risk domain
Knowledge of performance and scalability test practices and required tools
Great interpersonal and communication skills / Customer Facing skills
Experience working with agile software development methodology
Experience with different languages for automation scripting (VB, Payton, Java)

Specialist QA QRD Resume Examples & Samples

Diploma: Scientific university degree (Pharmacist, Engineer or equivalent)
Knowledge: Very good knowledge of English, GMP regulated environment, clinical trial and product development
Use of Pack Office (Word, Excel, PowerPoint)
Well organized– rigorous
Analytical and synthesis ability
Sense of observation and critical thinking
Good relationship : working within pluridisciplinary teams, sharing knowledge, listen to others

Specialist QA Resume Examples & Samples

Excellent understanding of product development in the mobility space
Good competency in developing effective solutions to diverse and complex business problems
Ability to work effectively across different stakeholder groups ranging from business analysts to product managers and developers to discuss Quality Assurance considerations and implications
Systematic, meticulous approach in managing tasks without being lost in the details and focused on overall objectives and timelines
High level written and spoken English communication skills coupled with fluent Mandarin are essential
Minimum a BA in either Computer Science Information Technology, Software Development or a related degree, or a demonstrated track record of expertise in test management and execution,
5+ years’ experience of manual/automation test management
At least 3+ years of Client management experience
Prior experience of both Agile (especially SCRUM) and Waterfall methodologies
Experience of automated test tools – Selenium and QTP
Experience of test management tools (QC, ALM, JIRA, etc.)
Strong stakeholder management skills able to communicate across delivery teams and business representatives
Experience in preparing Test strategy and planning
Proven experience in Smoke testing, Sanity testing, System testing, SIT and Regression testing
Thorough understanding of defect management process
High proficiency in both written and spoken Mandarin

Specialist QA Analyst Resume Examples & Samples

Define overall project test objectives
Design, write, and execute effective manual and automated test cases
Discover, reproduce, retest, and clearly document system defects
Plan, schedule, coordinate test activities for projects
5-8 years of experience in software testing
2 plus years testing enterprise level software
Demonstrated ability to create a test design and execution plan
Experience working with test driven development
Experience in Product Development teams
Experience authoring test plans from requirements
Experience in creating automation test scripts using Selinium
Test Management Tools (ALMComplete)
Excellent interpersonal skills and the ability to develop strong relationships
Higher education domain and system experience
Experience with accessibility testing
Working knowledge of Banner product(s)
Continuous integration and deployment

Specialist QA Engineer Resume Examples & Samples

Be involved in new features development; provide inputs to POs and Developers on the correct behavior of the system
Execute Risk Assessments and derive test coverage using ISTQB methods
Define, write and execute effective test cases for both Front and backend
Serve as focal point for all matters quality related and interface with offshore QA management
6-9 years of experience in testing backend systems
2+ of experience in testing front end systems
Experienced in E2E testing
Experienced in exploratory testing
ISTQB certification (preferably advanced test analyst level ) and able to apply this in a Scrum environment
Very experienced in Risk Based Testing
Excellent communication skills, both written and spoken, very good English
Experience with bamboo for deployment of code
Experience in coding C# and/or MS PowerShell scripting
Familiarity with Virtualization technology, VMWare, etc
Experience with protocol analysis and Wireshark tracing
Experience in and knowledge of Skype for Business and Cisco communication infrastructures is a plus

Specialist, QA Operations Resume Examples & Samples

Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 4years’ related experience; or Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 7 years’ related experience for the Specialist level
Ability to use Excel, Word, and other office systems
Understand and independently apply GMPs to everyday work with regard to documentation and review
Maintains high quality documentation in accordance with applicable regulatory guidance and Site SOPs
Prior work experience with quality management software (e.g. TrackWise®, ComplianceWire®, or similar applications)
Ability to learn, retain, and apply technical information on multiple topics
Develop and execute complex procedures with high quality
Understanding of pharmaceutical laboratory and / or production operations
Ability to complete investigation, deviation, and change control forms independently
Capable of rapid learning of unfamiliar principles or techniques with minimum training
Authors, edits and reviews Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports
Ability to problem solve to initiate and execute/monitor corrective action
Familiar with quality risk management, regulations and their context
Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines
Good working knowledge of quality systems and risk management
Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, FMEA, etc.)
Functional understanding of the FDA Drug Development Cycle
Demonstrated ability to understand and relay/incorporate expertise given from technical staff outside their area of expertise to their program
Ability to assist in technical calls for departmental projects as well as discussions regarding investigations or other issues
Recognize unmet customer and / or regulatory needs
Can effectively back-up supervisor to address limited technical or business issues with prior instructions

Senior Specialist QA Resume Examples & Samples

Expertise in root cause analysis and ability to transfer that knowledge to other staff
Enhanced skills in leading, influencing, and negotiating
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development
Demonstrated ability to interact with regulatory agencies
Advanced data trending and evaluation

Specialist, QA Esystems Resume Examples & Samples

At least 3 years of experience in Quality Control, Quality Assurance and/or IT in a pharmaceutical company or other related industry
Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements
Solid understanding of solid oral dosage form manufacturing/packaging and QC processes
Works independently, yet effectively in a team environment
Excellent investigational skills and QA problem solving skills, has a keen eye for Quality
Excellent written & oral communication skills in both English and French
Ability to focus and an attention to details
Knowledge of most common office software (Microsoft Office etc)

Specialist QA Resume Examples & Samples

Support of the Quality Process documentation such as review of procedures, training material and forms
Oversee, and in some areas implement, required actions to drive expected program performance
Monitor, evaluate and execute required changes to ensure organization’s success in managing Nonconformances and CAPAs
Provide training as required for Temperatures Excursions
Assess Temperature Excursions during distribution of Amgen Product
Utilize leadership skills to successfully influence outcomes, communicate with all levels of the organization and effectively define objectives to enable effective metrics generation and reporting
May support the Network for assigned quality process
Responsible for reviewing required data analysis, such as trend analysis and supporting required action to manage any identified area of concern
Working knowledge of Good Distribution Practices and EMA regulations
Previous on hands experience managing Nonconformance or CAPA programs
Experience managing investigation and leading implementation of improvement actions
Ability to read, analyzes, and interprets technical procedures, or governmental regulations
Strong problem solving and investigation skills
Ability to work on multiple projects within a deadline-driven environment
Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach
Working knowledge of MS Office tools, Cognos and Track-wise

Specialist, QA Validation Resume Examples & Samples

University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Good interpersonal relationship skills
Knowledge of GMP Regulated environment related to validation activities
Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures
Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA)
Support from a compliance point of view the MPU Product&Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders

Specialist QA Resume Examples & Samples

Initiate, coordinate and complete product complaint investigations
Interact with intake agents, other Amgen sites and business partners to ensure complaint process is followed
Reconcile reported product complaints to ensure accurate entry
Perform return sample coordination and ensure all required assessments are complete
Archive documents related to product complaints
Alert quality management of quality, compliance, supply and safety risks
Supporting Continual Improvement initiatives, programs and projects as well as the Audit and Inspection process
2 years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry
Self-motivated, attentive to details and able to prioritize and meet deadlines
Strong teamwork ability
Basic statistical mathematical skills including the ability to trend data
Independently understand, follow and implement instructions
Strong word processing, database and spreadsheet application skills
Strong organizational skills with the ability to manage multiple projects or assignments

Specialist QA Complaints Resume Examples & Samples

Provide guidance and support to the complaints team in regards to investigation of commercial complaints
Lead and manage product complaint investigations, product security investigations, safety quality investigations, trend investigations and consolidated investigations for Amgen commercial products
Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted supplier/manufacturers to resolve product complaints investigations
Act as Amgen Breda site representative in the Amgen product complaint network
Excellent written and verbal communication skills, including facilitation and presentation skills
Autonomous and self-motivated
Team player, able to work effectively with various levels and departmental groups
Influencing skills
Ability to prioritize and meet deadlines

Specialist, QA Resume Examples & Samples

Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility
Able to plan for future activities and coordinate with other departments to complete this
Develops skills to be Qualified Trainer in area of expertise
In depth awareness of entire process; identifying operational factors which influence the process
Participates in Regulatory and Customer Audits
Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports
Makes real-time decisions on process events on the floor based on knowledge of defined SOPs & policies
Develops good working relationships with internal & external customers
A competent Reviewer and Approver of SOPs, protocols, reports or records
Leads a small team and provides supervision to QA Coordinators, interns or QA Specialists I and II

Specialist QA-aml Resume Examples & Samples

Responsible for providing Quality oversight to ensure that operations for licensed pharmaceutical products are manufactured, tested, and stored, according to current Good Manufacturing Practices (cGMP) and other applicable regulations
Review and approval of Electronic Batch Records and related documentation to support Drug Product Disposition Process
Performs SAP systems transactions to support batch processing and disposition requirements
Data entry, review and approval of LIMS sample test results to support batch processing and disposition requirements
Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformance’s, CAPAs, and validations
Supports Continual Improvement initiatives, programs and projects
Ensures that deviations from established procedures are investigated and documented per procedures
Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
Represents the quality unit during audits and inspections as needed
Performs additional duties as specified by management
Enhanced skills in leading, influencing and negotiating
Collaborate and coordinate with higher level outside resources
Strong knowledge of and experience with processes involved in manufacturing, QA, QAL, validation and process development
Strong skill in working independently and to effectively interact with various levels

Specialist, QA Fresh Resume Examples & Samples

Computer skills in a Windows environment: SAP, Excel, Outlook, Office 365
Ability to communicate (verbally and written) effectively inter-departmentally and at various levels throughout the organization
Ability to work independently and as part of a team in a fast paced, 24/7 refrigerated warehouse environment
Self-motivated, detail oriented, analytical and organized
Raise the bar regarding company QA standards and exceptions and embrace a continuous improvement philosophy
Requires ability to stand for long periods of time and lift up to 70 lbs on a repetitive basis
Must be able to work day/afternoon/night shift, weekends, holidays, etc
Shift assignment is subject to change depending on business requirements

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