Quality Specialist Senior Resume Samples

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B Balistreri

Bethany

Balistreri

53524 Marks Wells

Los Angeles

+1 (555) 189 9587

53524 Marks Wells

Los Angeles

Phone

p +1 (555) 189 9587

Experience Experience

New York, NY

Quality Assurance Senior Specialist

New York, NY

Simonis Inc

New York, NY

Quality Assurance Senior Specialist

11) Providing Quality Leadership and oversight for risk management across the Site
Performs internal audits and keep management informed of identified findings
6) Providing Quality oversight for Deviation Management Program
5) Performing review and approval of automation changes
Provide quality assurance of our system
Process Change Management
12) Performing internal audits

Philadelphia, PA

Quality Assurance Specialist Senior

Philadelphia, PA

Kautzer, Streich and Jacobs

Philadelphia, PA

Quality Assurance Specialist Senior

Assist Application Developers and technical support staff in identifying and resolving problems
Define and establish overall User Acceptance Testing (UAT) quality approach
Assist in designing and ensuring overall integrity of the automated testing strategy
Develop automated testing processes and approaches according to JPMC Chase, and Six Sigma/CMM standards
Execute and maintain UAT test cases and test scripts
Perform the tests in both the QA and contingency/backup environments
Assess readiness and deviation of product/project performance based upon test results and product specifications

present

Phoenix, AZ

Senior Audit & Quality Specialist

Phoenix, AZ

Leannon, Robel and Rogahn

present

Phoenix, AZ

Senior Audit & Quality Specialist

present

Key Measures of
Completing all aspects (i.e. planning, execution and reporting) of assigned integrated audits, in accordance with Business Improvement and Regulation audit processes
Promoting continual improvement throughout the business
Preparation of information and data for management review process
Regulatory background as it applies to general and vocational qualifications
Good attention to detail and accuracy when reporting of activities and analyses
To recommend and promote practical and cost effective actions for improving the effectiveness of business processes and to monitor and support to ensure the successful completion of action plans

Education Education

Bachelor’s Degree in Chemistry

Washington State University

Bachelor’s Degree in Chemistry

Skills Skills

Typically 5+ years of experience and demonstrated success at the highest level of the functional area as well as demonstrated success in a quality role
Ability to improve processes
Knowledge of MS Office (Excel & Access)
Excellent written and verbal skills
Ability to complete audit work and analyze results
Problem solving & critical thinking skills
High level of technical skill in functional area
Organizational and follow up skills

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Senior Lead Quality Specialist Resume Examples & Samples

In-depth knowledge of systems development processes and methodologies (e.g. SDLC, RAD, RUP) covering the entire system development lifecycle
In-depth knowledge and experience in implementation of software quality assurance and software process improvement
Knowledge of industry used Project Management tools such as Clarity or MS Project
Knowledge in the SEI CMMI process improvement framework and experience in conducting CMMI appraisals
Good command of spoken and written English
A self-starter with ability to work independently with a strong sense of ownership
Strong leadership ability, motivating IT employees
Experience in conducting project health checks and project quality reviews
Experience in mentoring or providing consultancy support to project management community
Proven experience in an IT leadership role
Proven experience of project management, project management tools and practices
Typical qualifications would include an undergraduate degree

Senior Audit & Quality Specialist Resume Examples & Samples

Key Measures of
Promoting continual improvement throughout the business
Training and supervision of other members of staff as required in relation to the audit functions
Review and maintenance of department procedures and documentation relating to audit, as required
Provision of appropriate management information to the Audit and Quality Manager as required
Preparation of information and data for management review process
Participate in, and lead when appropriate, cross-departmental monitoring, audit and other project activity
The Senior Auditor and Quality Specialist will also support the broader work of Business Improvement and Regulation by working across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring, business continuity and data protection, when required to do so Experience, Skills and Qualifications Previous Work Experience
Assisting the Audit and Quality Manager on the planning and scheduling of audit activity as part of an integrated audit programme covering Pearson UK sites and Pearson suppliers as required by senior management
The Senior Auditor and Quality Specialist will also support the broader work of Business Improvement and Regulation by working across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring, business continuity and data protection, when required to do so

Senior Plan Document Quality Specialist Resume Examples & Samples

Advanced knowledge of plan documents and investment products
Advanced knowledge of Transamerica products and administrative capabilities, and plan-related information
Superior problem solving skills to analyze case situation and formulate appropriate action plans
Strong verbal and written communication skills to respond to inquiries by clients and internal Transamerica representatives
8+ years of pension or plan experience
Ability to independently handle more complex plan issue

Senior Audit & Quality Specialist Resume Examples & Samples

To deliver, either solo or in a team, high quality, commercially focussed audits and advisory reviews that fulfil business needs/requirements
To recommend and promote practical and cost effective actions for improving the effectiveness of business processes and to monitor and support to ensure the successful completion of action plans
Identify best practice and work alongside management to deliver and implement pragmatic, commercial action plans
Undertake the lead or support of specific projects as required by line management
Collate management information for Management Review as required by the Head of Audit and Quality, Audit and Quality Manager and/or other senior management within Business Improvement and Regulation
To perform supervisory responsibilities in accordance with good practice and the Pearson people manager policies

Senior External Manufacturing Quality Specialist Resume Examples & Samples

Bachelor's Degree in engineering or a related field
6 years within a supplier quality organization
4 years in the Medical Device or Pharmaceutical industry
Master's Degree in engineering
Demonstrated working experience and expertise in CAPA and non-conformance systems
Extensive experience regarding root cause analysis and statistical techniques
Familiar with 21 CFR Part 210, 211, 820, ISO 13485, and ISO 14971

Senior Audit & Quality Specialist Resume Examples & Samples

Ensure Pearson's compliance with internalprocedures, regulatory requirements and external business standards such asISO9001 (Quality Management), ISO27001 (Information Security) and ISO22301(Business Continuity)
To deliver, eithersolo or in a team, high quality, commercially focussed audits and advisoryreviews that fulfil business needs/requirements
To recommend andpromote practical and cost effective actions for improving the effectiveness ofbusiness processes and to monitor and support to ensure the successfulcompletion of action plans
To assist in thedevelopment and implementation of processes, policies and procedures as aresult of reviews of current business practices
Identify bestpractice and work alongside management to deliver and implement pragmatic,commercial action plans
To communicateeffectively, both verbally and in writing with internal and externalcolleagues, customers and senior managers
Undertake the leador support of specific projects as required by line management
Collate management informationfor Management Review as required by the Head of Audit and Quality and theAudit and Quality Manager or other senior management within BusinessImprovement and Regulation
To performsupervisory responsibilities in accordance with good practice and the Pearsonpeople manager policies
To liaise withexternal agencies, including Ofqual, SQA, EAB and JCQ, as required inconnection with the role

Quality Assurance, Senior Specialist Resume Examples & Samples

Maintain state of the art audit program
Bachelor’s degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
Experience with electronic quality management systems is preferred
Innovative, proactive, and resourceful; committed to quality and continuous improvement
Knowledge and hands-on experience in regulatory inspections, vendor audits, and vendor qualification is required
Occasional travel up to 10-20% of time

Senior Specialist of Quality Assurance Resume Examples & Samples

Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products
Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills
Laboratory Experience or assay development experience preferred Knowledge of Compendia preferred
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer

Senior Lead Quality Specialist Resume Examples & Samples

Day to Day management of contractor labs for Potency Testing Schedule for Acthar Program
Acting as Program Manager for Potency testing activities – new methods, method improvements, Stability testing
Liaison between Science and Technology, GES and Corporate teams for matters concerning Acthar Potency testing
Subject Matter Expert on all Achtar Potency Testing
Building technical knowledge base for potency testing – understanding factors which influence test and building a problem solving program to assist in testing troubleshooting
Lead Analytical Method Transfer activities when required to other third party and internal lab testing
Lead testing life-cycle initiatives to bring method improvements forward
Making fact-based, scientifically sound, quality decisions regarding testing within the requirements of cGMPs and applicable regulatory/industry guidance documents
Ensuring that the Performance of the testing is concurrent with Standards and Regulations that are applicable to the specific testing types
Translate complex engineering, manufacturing, and quality technical data into understanding format for executive presentations, managerial feedback and lab feedback
Reviews and analyzes corrective action reports and purchase orders in an effort to reduce and eliminate defects
Monitors quality control activities and systems at supplier and subcontractor facilities
Audit third party manufacturers, due diligence and vendor selection process
May perform deviation investigations into quality issues
Will perform elements of Program Management and Troubleshooting as needed
10-15 years related Pharmaceutical experience (both API & Drug Product)
5+ years’ experience in a managerial role

Senior Technical Quality Specialist Resume Examples & Samples

Experience with SQL and relational database concepts
Experience with test automation tools and/or software
Experience in development concepts and architectures
Excellent written & verbal communication skills. Must possess excellent interpersonal and communication skills to interact with all levels of management, business partners and application developers
Business acumen
Strong interpersonal and client consultation skills
Self-motivated and results-oriented
Problem solving & troubleshooting capabilities
Project management knowledge
In-depth analytical skills
Superior organization abilities
Process & procedure oriented
Experience with creating project test strategies and test plans
Experience with Continuous Integration a plus
Must possess excellent interpersonal and communication skills to interact with all levels of management, business partners and application developers
Must possess strong time-management, analytical, problem-solving and presentation skills
Thorough understanding of Quality Assurance as it relates to system development
Ability to interact effectively with IT and business individuals/teams at all organizational levels
Ability to effectively communicate to management risks, issues, alternatives, and recommendations

Bioresearch Quality Assurance Senior Specialist Resume Examples & Samples

Training & Development
Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology
Knowledge of procedural and records management requirements in a regulated industry preferred

Senior Surface Quality Specialist Resume Examples & Samples

Master's Degree in Engineering Discipline from an accredited school
Experience and knowledge of aluminum rolling and finishing operations
6 years of hands on experience maintaining and using SQM systems
Proven track record of utilizing SQM systems to reduce customer claims and internal scrap
Demonstrated effectiveness working on teams with evidence of leadership potential
Demonstrated ability to operate in an advisory and collaborative role with internal and external customers

Quality Assurance Specialist Senior Resume Examples & Samples

Define and establish overall User Acceptance Testing (UAT) quality approach
Identify and coordinate UAT activities with user acceptance testers
Translate business requirements into UAT test plans, test cases, and test scripts
Execute and maintain UAT test cases and test scripts
Track UAT test cases, test scripts, and results
Coordinate production release business validation

Senior R&D Quality Assurance Specialist Resume Examples & Samples

The QAE will implement and maintain the quality system
Generate quality processes such as procedures, protocols, and reports
Report on the performance of the quality system and provide improvements if needed
Determine and enforce through functional groups the quality and regulatory requirements in accordance with company needs, based on current regulations and industry accepted best practices
Manage and coordinate calibration systems
Develop and implement corrective/preventative action plans
Manage the supplier quality system
Manage and coordinate Instrument Qualification, Operational Qualification, Performance Qualification activities
Management representative for the company
Primary point of contact with all external parties on matters relating to the quality system and regulatory affairs
Develop and organize companywide quality improvement efforts
Promote awareness throughout the organization of current good manufacturing practices including how the quality of our products may impact patient health and safety
Directly and through staff will identify and implement improved techniques for the control of quality, reliability, and safety
Participate in product development (research and development activities) as part of a Project Team
Demonstrated mastery of the principles in 21 CFR Part 820, ISO 13485 and ISO 14971
Experience with FDA regulatory submissions and in-depth knowledge of quality management system requirements
Ability to successfully host audits from customers and regulatory agencies
Keep up to date with best practice in Quality
Ability to work autonomously with minimum supervision
Demonstrated problem-solving and decision-making skills
Ability to deliver and meet deadlines
Good communication skills, capable of communicating ideas to colleagues and customers
Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)

Senior tea Quality Specialist Resume Examples & Samples

Manages tea and botanical quality by tasting and evaluating flavor profile of teas and botanicals at different stages of testing
Manages tea and botanical blend formulation activities to ensure consistent high quality blends while balancing cost considerations and meeting demand plan
Determines quality and appropriate usage
Develops and implements initiatives to allow for cost improvements, quality enhancements, and supply chain integrity
Communicates results and quality issues throughout approval process
Supports consistency in manufacturing by evaluating tea and botanical inventories at warehouses, blending facilities, and distribution centers
Coordinates test requests of new recipes, including creation and delivery of test request, disposition of test batches, development of flavor profile description, and updates of manufacturing specifications
Monitors tea blend flavor profiles throughout crop year cycles
Consults with manufacturing to determine dispositions for tea and botanical matters such as blending decisions
Manages tactical tea and botanical position for blending facilities and warehouses
Makes recommendations to quality manager and tea leadership for strategic recipe planning based on current/future qualities and inventories
Executes recipe changes for all tea blends
Executes new recipe and item setup for all new tea recipes and usages
Trains and develops tasting room personnel
Approves tea related content by reviewing written tea related materials. Coaches business units to support initiatives involving tea communication and education
Conducts tastings and trainings for senior management, the trade, consumers, and print and broadcast media
Implements procedures to support quality specifications. Analyzes supplier performance against metrics developed by Global Tea Quality
Assists in the development of appropriate tea training materials
Supports tastings and SSC activities as needed
Experience with tea and/or botanical tasting or using other sensory stimuli -5 years
Experience with inventory management and quantitative calculations - 3 years
Experience and knowledge of tea and botanical blending - 5 years
Education (ideal education level or degree): Bachelor’s Degree Preferred
Leadership and management skills
Budgeting and cost analysis skills

Senior NC / Capa Quality Specialist Resume Examples & Samples

Facilitate implementation of CAPA and NC systems
Mentor, coach,and guide users of the CAPA and NC systems,Including;problem definition,root causeInvestigation,CAPA action determination,CAPA effectiveness
Monitor quality of CAPA and NC records and work with owners to address issues
Contribute to the continuous improvement of the CAPA and NC systems based on use patterns and user feedback
Develop, Implement and manage CAPA review board
Develop and report quality metrics on CAPA and NC performance
Assist functional areas with systematic problem-solving methodologies when resolving quality issues
Bachelor of Science degree in an engineering discipline (Mechanical,Biomedlcs, materials,lndustrlal,etc) or related technical field (microbiology,chemistry, etc) is required
ASQ Certification preferred but not required (such as CQA, CQE,CMQ/QE)
Demonstrated working experience and expertise In CAPA and non-conformance systems
Excellent communication skills (verbal and written).ExperienceIn problem solving and root cause illnalysis
Ability to successfully Influence others within project teams regarding quality or compliance concerns
Minimum 10 years with CAPA and NC in the Medical Device or Pharmaceutical
Industryls required), including;root cause analysis and statistical techniques such as Cause and Effect Analysis,s Whys,Six Sigma processes
Ability to motivate and mentor users to increase proficiency with CAPA and NC management

Senior Proposal Quality Specialist Resume Examples & Samples

Masters’ Degree in international relations, development, journalism, business, or a related field and minimum of nine (9+) years’ experience working on USG-funded proposals/programs
Minimum six (6+) years of business development/proposal development targeting USAID and other donors
Excellent writing, editing and verbal communication skills
Demonstrated track record in writing winning donor-funded technical proposals, including USAID
Ability to interact effectively with senior staff, external clients and stakeholders, including a proven ability to build consensus and relationships and influence and motivate teams to achieve goals
Highly-detailed, strategic thinker with substantial capacity to thrive in deadline-driven, dynamic environments
Software Proficiency: Microsoft Office Applications (required); SharePoint and/or Salesforce (preferred)
Native fluency in English is required; fluency in Spanish or French is strongly preferred
Domestic and international travel is required
Must be eligible to work in the U.S. without sponsorship

Quality Assurance Specialist Senior Resume Examples & Samples

Associate's Degree and 3 years related experience
In-depth knowledge of automated testing tools (e.g., WinRunner), quality control, and quality assurance approaches
Software Test Engineer (CSTE) or Quality Analyst (CQA) certification

Quality Specialist Senior Resume Examples & Samples

Typically 5+ years of experience and demonstrated success at the highest level of the functional area as well as demonstrated success in a quality role for a minimum of 1 year
Ability to improve processes
Ability to complete audit work and analyze results

Quality Assurance Specialist Senior Resume Examples & Samples

Leads the effort to work with software developers to resolves issues of incompliance through system modification, reconfiguration or workarounds. Establishes objectives for testing cycles. Develops test scenarios for unit, process, function, integration and acceptance testing
Leads the team in planning and estimating quality assurance support requirements for new products, new functions and new components. Leads audits and reviews
Oversees and leads the efforts to monitor adherence to quality standards in the development, implementation and upkeep of software products. Monitors effectiveness of the assurance process and tools
Oversees the tracking of quality assurance metrics such as defect density and open defect counts. Oversees team members responsible for testing and inspection of products to determine compliance with specifications

Quality Assurance Specialist Senior Resume Examples & Samples

Monitor core, management, and support processes within their assigned areas to assure implementation and effectiveness
Conduct Program Management Inspection (PMI) to assure compliance with the Statement of Work (SOW) and Company procedures
Conduct Equipment Condition Inspection (ECI) of aircraft and ground support equipment to assess the effectiveness of inspection and maintenance processes
Assess and report conformance and nonconformance
Conduct Personnel Evaluation (PE) to evaluate the knowledge, skill, and ability of personnel and assess the effectiveness of our technical training and certification program
Conduct Technical Inspection (TI) of work in progress and completed maintenance actions to assure compliance with Technical Data and evaluate the effectiveness of DI processes
Conduct Environmental Health & Safety (EHS) Inspection of work areas and activities to assure compliance with NASA and DI safety policies and procedures to include proper use of Personal Protective Equipment (PPE)
Provide oversight of support programs listed in the NASA AMOS Work Breakdown Structure (WBS)
Monitor documentation and records generated by all departments for compliance with NASA, FAA, and DI requirements
Ensure the proper and timely execution of FAA Form 337 for major repairs and alterations of FAA Type Certificated (TC) aircraft, engines, propellers, and appliances
Participate in Quality Management System (QMS) audits to assess conformance to standards and effectiveness of core, management, and support processes
Participate in vendor audits to assess their capability to deliver products and services to specifications and effectiveness of their QMS to assure quality and on-time delivery
Document and report daily monitoring and assessment activity including findings of conformance or nonconformance in QT9
Conduct validation audit to confirm implementation and continued effectiveness of corrective actions
Conduct training and examination of Designated Systems Inspectors (DSI) and DSI candidates
Provide technical supervision and oversight of DSIs performing production inspection activities
Conduct monitoring, surveillance, and recurring assessment of DSIs
Perform production inspection activities when qualified DSIs are unavailable or QA oversight is required
Conduct supply receiving – conformity/airworthiness inspection of repaired or manufactured items
Conduct investigation of nonconformance, malfunctions, defects, incidents, anomalies, etc
Establish and maintain QMS documentation and records
Create, review or approve (as authorized by Quality Manager) documentation such as EWO’s, TO TDR, OTR, and OTI
Assist all departments with data collection, troubleshooting and analysis
Participate in performance/process improvement activities
Provide training of other employees as well as assisting them in the performance of their job assignments through coaching, counseling, and guidance
Assist in development and validation of technical training
Perform other qualified duties as assigned
Knowledge of inspection and testing software systems
Ability to understand how test equipment can influence production
Ability to plan for and carry out long-term projects and develop forecast
Demonstrated attention to detail and quality throughout all production lines
Able to obtain and maintain a Secret security clearance
Five (5) or more years of hands-on experience in an aircraft maintenance quality assurance position
FAA-certificated Mechanic with Airframe and Power Plant ratings and current Inspection Authorization preferred

Senior External Manufacturing Quality Specialist Resume Examples & Samples

6+ years of experience within a Supplier Quality organization; 4+ years of experience in the Medical Device or Pharmaceutical industry
Bachelor's and/or Master's Degree in an Engineering discipline (Mechanical, Biomedics, Industrial, etc) or related Technical field (Microbiology, Chemistry, etc.)
Experience in Electronic Quality System modules, such as ComplianceWire, CATSWeb, Documentum, QlickView, etc
ASQ certification (such as CQA, CQE, CMQ/QE)

Senior Mortgage Quality Assurance Specialist Resume Examples & Samples

Perform risk analysis, data integrity and make decisions regarding deficiencies identified during the review process. Review and analyze mortgage applications, credit reports, appraisal, income and asset documents to determine accuracy and completeness per guideline requirements
Provide training as needed to educate group/team the details of the Pre-Funding/Funding Audits provided by the Quality Assurance specialist. Communicate with appropriate individuals to ensure that deficiencies are cleared within required timeframes
Ensure that deficiencies captured during the review process are corrected and clearly documented providing a thorough audit trail
Participate in departmental projects as required
College education or comparable supplementary education with related work experience
At least five years of single-family mortgage related experience with a Bank or Mortgage Lending operation
Minimum four to five years quality control or single-family loan underwriting experience, both conventional and government loans
Loan compliance/audit experience preferable
Documents work performed; records deficiencies discovered throughout the course of the review and evaluates the quality of the files audited
Records evaluation in database for future compilation into a management report
Reviews responses setting forth any corrective action taken as a result of reported findings
Analytical thinking, problem solving, research and stress management skills
Exhibit a pleasant demeanor with clients and internal personnel via phone and email
Able to communicate with all levels of management, other departments and customers
Excellent math aptitude
Strong ability, desire and enjoyment in working with others, both employees and customers, in a firm, cooperative, courteous, professional and friendly spirit
Knowledge of computer applications, including Microsoft Windows, Word, Excel and Outlook. Ability to learn new software applications as required
A self-starter, dependable, accurate in completing responsibilities with strong attention to detail and organizational skills
Able to work within deadlines and under extreme pressure
Able to learn quickly, ask questions, take instruction constructively and be flexible in doing assorted tasks
Regular and punctual attendance required

Senior Business Quality Specialist Resume Examples & Samples

Reviews reports on current quality systems and supports improvements in order to enhance quality
Support Escalation process of Quality Compliance matters
Monitors trends, identifies issues, recommends and implements appropriate actions
Management of product complaints, timely reporting into local system, data trending
Handling Customer Complaints
2 years+ experience in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
Knowledge of GMP and GDP preferred
It is preferred that the job holder is an experienced internal auditor or certifies lead auditor
English on upper-intermediate level as a must
Excellent interpersonal, collaboration, networking and communication skills
Readiness for business trips000019CQ

Senior R&D Quality Specialist Resume Examples & Samples

Reviews the operations involved in the compounding and filling of drug product to ensure compliance to established operating and manufacturing procedures
Verifies the performance of critical operations and activities
Reviews compounding documentation and dispositions bulk products for further processing
Investigates and resolves manufacturing and microbiological excursions
Reviews investigation records generated by PAM Microbiology Lab and interprets data for accuracy and completeness
Reviews and approves documentation and standard operating procedures relating to Microbiology, aseptic practices, and facility certification

Senior Customer Service Quality Specialist Resume Examples & Samples

Utilizes working knowledge of processing and quality functions, compliance with state and federal regulations, SOX, SEC, IMSA and quality functions in the Customer Contact Center
Verify and monitor the accuracy and completeness of information provided by others to ensure quality of service
Provides support for entry or intermediate level Customer Service Quality Specialists
Report and document deficiencies and/or inconsistencies in procedures, which affect quality or create potential problem situations. Work with management staff on resolutions. Actively recommend quality standards and process improvements as appropriate
Regularly audit the work within the teams for accuracy and adherence to procedures, provide one on one coaching or training recommendations to management on areas requiring improvement
Provide support to other teams as needed with resolving customer problems, processes, procedures, and customer satisfaction and resolution as primary objective
Attend and participate in various meetings with feedback and reports on quality assurance service levels, results, and recommendations for process improvements
Remain abreast of current procedures and changes
Participate in the development and implementation of a QA Reward and Recognition program
Review the work of others to ensure compliance with company policies, department policies SOX, federal and state regulations
Know all work types and business units
Identify improvement process and assist with training of team members

Quality Assurance Senior Specialist Resume Examples & Samples

Facilitates adherence to established quality system and compliance with respective regulatory agencies
Performs internal audits and keep management informed of identified findings
Write and revise SOP’s as needed
Performs review and approval of protocols, reports, and SOP’s
Maintain oversight of established training program with associated records
Identify potential quality system improvements to maximize quality and efficiency
Manage all assigned projects through to completion
Maintain continuous learning to keep abreast of regulatory or industry standards as relates to Quality Assurance requirements
Work independently and efficiently
Communicate effectively with client and co-workers
Ability to work independently and as part of a team, high integrity, self-motivation, adaptability, and a positive attitude
Bachelor's degree in Chemistry, Biology, Regulatory Affairs or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
3 years relevant laboratory/quality assurance experience in a regulated lab environment, with preference for GLP or cGMP

Quality Assurance Senior Specialist Automation Resume Examples & Samples

Minimum of 3 years experience in cGMP regulated industry supporting computer systems and computer systems validation
Experience in one or more functional areas such as quality assurance, quality control, manufacturing or engineering
Experience with qualification of automation systems in a Pharmaceutical or Biotechnology environment is highly preferred
Computer systems development methodology is preferred
Technical writing experience in a cGMP environment
Prior supervisory/management experience is a plus
Strong leadership skills with the ability to effectively communicate with wide variety of customers

Senior Hardware Quality Specialist Resume Examples & Samples

8+ years of general hardware quality inspection experience
Experience working in a manufacturing environment with accept and reject criteria for general quality workmanship
Experience working with assembly build processes, interpreting drawings and/or contractual flow down
Electro-mechanical manufacturing background
Experience presenting deliverable hardware assemblies to DCMA (Defense Contract Management Agency) for final hardware acceptance
Good organizational skills and ability to effectively coordinate multiple activities; self-motivated and ability to work with minimal supervision
Personal ownership and accountability, the ability to find solutions in difficult situations
Proven ability to work proactively with others, driving decisions while also functioning as a team
Ability to walk back and communicate concerns to operations and support team
ASQ certified Inspector
Associate’s Degree or related experience with certification

Senior R&D Quality Specialist Resume Examples & Samples

Maintains proper control of operations’ documentation by following SOP’s, manufacturing procedures, GMPs, ISO requirements, OSHA guidelines and other pertinent regulatory requirements
Format and edit controlled GMP/GLP, R&D and related documents and forms as requested through change control
Route documents for review and approval using the electronic docbase. Obsolesce and archive documents as required
Maintains both electronic and manual system files for change control documentation and current master records adhering to corporate and regulatory standards and regulations
Maintains database indices for the document change control system
Tracks the status of changes in the system
Maintains program for handling obsolete documentation and history files for archived records
Issues Master Records and other required documents for Pharmaceutical Science Operations
Conducts electronic database training for all new employees and assist Pharmaceutical Development (GMP) organization with the document processing related issues
Responsible for maintain indices & relevant records for documents sent offsite for archival
Supports the offsite archival process by coordinating with document owners and off-site vendor
Performs other assignments such as assistance with administrative support for assigned quality tasks and supporting Group Trainings, Annual training program, etc. as assigned by Manager
Thorough knowledge and experience with documentation systems and control techniques
Knowledge of computer databases, technical writing, and word processing principles, techniques and concepts necessary to maintain documentation change control system
Thorough knowledge of GMP concepts relating to a Pharmaceutical manufacturing environment and controlled documentation
Detail oriented with strong organization and coordination skills
Good analytical and communication skills, both written and oral
Good interpersonal skills with strong team player orientation
Ability to interpret and conceptualize manufacturing and analytical methods, processes and SOPs into a controlled system for traceability, retrieval, audit, review and approval
Strong computer skills, especially in a Windows operating environment
Training and experience equivalent to Bachelor’s degree in general science with an emphasis in administration, computer with four years of industry experience
Experience in the GMP quality, analytical laboratory or manufacturing functions is preferred

Senior Logistics Quality Specialist Resume Examples & Samples

Planning, coordinating and monitoring of re-/qualification and re-/validation activities of all CSL transportation systems and processes, including worldwide suppliers and customers
Creating and maintaining reports on the state of qualification within the Logistics Quality management systems
Directing and monitoring of internal and external staff in the preparation and execution of qualification documents, such as Qualification plans, protocols and reports
Maintenance/management of a valid qualification and validation status
Correct documentation of the qualification results
Review validation documents provided by transport system providers for adequacy in use for CSL products
Prepare Risk Assessments to support the introduction of new transport systems
Prepare Validation Statements to be used in regulatory submissions or on agency requests
7+ years in GMP Quality, GMP Operations, or GMP Operations Support
Demonstrate extensive experience in Good Distribution Practices
Demonstrate extensive experience in Technical Writing and Good Communication Skills
Demonstrate extensive experience in Transport Validation or Equivalent
Demonstrate experience in negotiation skills, with clients and suppliers
Demonstrate experience in project implementation
Demonstrate personal skills required for team leadership
Experience in Logistics is an advantage
Qualified GMP Auditor is an advantage

Quality Assurance Senior Specialist Resume Examples & Samples

1) Coordinating BPDR/FAR activities, including oversight of the BPDR meeting
2) Coordinating Fact Finding, Recall Committee, and Market Action activities
3) Performing and coordinating Product Quality Complaint/Adverse Event activities including PQC intake, handling sample returns, investigations, and compilation and analysis of PQC and AE data
4) Working within the Change Control System to ensure requirements are met. Running IPT Advisory Council meetings
5) Performing review and approval of automation changes
6) Providing Quality oversight for Deviation Management Program
7) Performing review and approval of deviations
8) Authoring Annual Product Reviews (APRs)
9) Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site
10) Providing Quality oversight of supplier information across all categories of suppliers that service WP
11) Providing Quality Leadership and oversight for risk management across the Site
12) Performing internal audits
13) Participating in regulatory inspections, including facilitating and RMT activities
14) Presenting system overviews to regulators as needed
Lead and facilitate compliance projects to support sustaining and/or enhancing compliance
Lead and facilitate MPS projects to support enhanced efficiency and effectiveness
Support ad-hoc data requests and analysis
Author, review, and approve procedures and other control documents
Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors
Assist with aspects of Regulatory Inspections and commitments
Participate in internal audits and shop floor inspections
Execute market actions, Regulatory Agency Communications (FARs, BPDRs)
Performing and coordinating Product Quality Complaint/Adverse Event activities
Process Change Management
CAPA Management
Automation Compliance
Performing gap analysis and remediation
Quality Support/ownership for applicable automation systems
Regulatory surveillance
Conduct training on compliance topics
Execute projects as required by the Associate Director
Minimum 5 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility
Strong analysis and critical thinking skills are required for this position
Ability to function effectively with ambiguity, changing priorities, and aggressive deadlines
Ability to make risk-based decisions
Excellent technical writing skills are required along with strong editing skills
Vendor collaboration/relationship, and influencing skills
Ability to drive results and influence others in the areas of data requirements, Regulatory/compliance issues, and timelines
Project management and facilitation skills required to drive projects to completion
Strong business process analysis skills for areas/processes for streamlining, and process re-engineering to enhance value proposition of function
Ability to work as part of a high performing team: good collaboration skills, high level of emotional intelligence, ability to maintain objective viewpoints

Brqc Quality Assurance Senior Specialist Resume Examples & Samples

Position Title: BioResearch Quality Assurance / Senior Specialist
Sector: Janssen
Location
Teaming & Collaboration
Prior pharmaceutical and quality/compliance related experience preferred
Sound problem solving and good negotiating skills
Quality mindset

Senior Crude Oil Quality Specialist Resume Examples & Samples

Maintain and continue to develop current Crude Oil Quality Oversight Program and data base. This data base includes the on-line and composite analytical data which needs to be evaluated for compliance with industry standards, regulatory requirements and relevant commercial terms
Review and evaluate the results of composite samples and on-line quality data to confirm products meet the specifications
Issue violation letters to shippers who deliver products that don’t meet Energy Transfer quality specifications published in most current Tariffs, Rules and Regulations
Work closely with shippers and 3rd party facilities to resolve issues with noncompliant shipments
Maintain expert level working knowledge and understanding of crude quality processes and industry practices
Monitor performance and accuracy of the laboratory and on-line testing equipment within the areas of responsibility, as associated with crude quality assurance sampling and testing
As required, be available to witness the equipment calibration and verification activities, such as lab testing equipment and on-line analyzers
Stay current with relevant API Standards/Recommended Practices and ASTM Test Methods
Under general supervision by the Quality Manager, work with control center, operations, and scheduling groups to resolve specification violations and/or perform Root Cause Analysis Investigations
Work with field operations to ensure that proper test methods are being followed
When requested by Management, participate in crude oil blending and optimization programs
Coordinate activities with other groups within Measurement and Quality Department
As required, audit the internal and 3rd party laboratories to ensure that testing equipment and practices continue to meet all commercial and regulatory requirements
As necessary, audit compliance of pipeline and terminal operations with the established quality procedures
Provide direction to contracted labs to ensure proper testing of oversight and/or assay samples; monitor lab performance and provide appropriate feedback to management
Inform and train relevant company personnel on quality testing, potential issues, initial response and determination of appropriate resolutions
Prepare quality budget recommendations for improvement of operations at the Pipeline and Terminal facilities
Consistently maintain and demonstrate a high regard for personal safety, for the safety of company assets, employees, and the general public

Senior Specialist GAH Quality Assurance Resume Examples & Samples

Provide end user training for Reliance
Grant user access for new users and edit permissions for existing users
Provide end user support as needed during Hypercare
Minimum of (5) years Business Analyst experience
Minimum of (1) year Reliance support experience
Experienced computer skills using MS Office (Outlook, Word, Excel, Power Point, etc.) and operation of other peripheral devices
Ability to understand end user issues, diagnose the root cause and resolve issues
Professional communication skills
Ability to manage multiple priorities in a fast paced environment