Senior Quality Assurance Specialist Job Description
Senior quality assurance specialist
provides support for investigations into non-conformances, CAPAs and complaints to maintain compliance with ISO13485 and FDA (21 CFR) part 820 requirements, through the use of quality investigational tools.
Senior Quality Assurance Specialist Duties & Responsibilities
To write an effective senior quality assurance specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included senior quality assurance specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Independently lead audit planning, conduct and report on BioResearch Quality Assurance routine and non-routine audits of activities, data, internal facilities and processes in GxP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements
Responsible for SAP transactions relevant to disposition
Ensure products meet regulatory requirements any partner requirements
Participate as QA representative on Shire Technology Transfer teams to support product tech transfers into Shire US manufacturing plants
Conducting internal audits, supplier audits, and coordinating external audits
Recording and rating audit findings to clearly indicate the nonconformities and the level of regulatory risk posed
Representing the company on medical device quality and regulatory matters before standards and regulations auditors
Oversee the Annual Product Review Process and other quality initiatives
Ensure timely and quality execution of the annual reports for the pharmaceutical product lines
Provide routine analysis of performance indicators
Senior Quality Assurance Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Quality Assurance Specialist
List any licenses or certifications required by the position: ISO, 9001, CQA, ACRP, N45, ANSI, PMP, ITIL, ASQ, CAMS
Education for Senior Quality Assurance Specialist
Typically a job would require a certain level of education.
Employers hiring for the senior quality assurance specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Science, Chemistry, Biology, Technical, Microbiology, Education, Computer Science, Manufacturing, Life Science
Skills for Senior Quality Assurance Specialist
Desired skills for senior quality assurance specialist include:
Regulatory requirements
Application of concepts
Principles
Technical capabilities to perform varied tasks
Regulatory requirements and guidelines for US and Europe
Quality systems and approaches
SAP
21 CFR 820
CAPA management
Change control
Desired experience for senior quality assurance specialist includes:
Use Lean/six sigma tools to identify areas of improvement
Lead investigations using root cause analysis tool
Propose/implement systemic corrective actions
Identify systemic corrective actions
Lead initiatives to implement corrective action
Approving CAPAs associated within the QA unit
Senior Quality Assurance Specialist Examples
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Senior Quality Assurance Specialist Job Description
Job Description Example
Our company is looking for a senior quality assurance specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior quality assurance specialist
- Will serve as Subject Matter Expert for internal or external matters
- Is proficient in technical and non-technical
- Assist in complaint management in material review boards
- Prepares/manage all written records of all inspections and audits
- Undertake or ensure completion by other project personnel, audits of phone customer service and desk re-reviews of sample cases, develop, maintain and report upon quality data from these audits
- You’ll estimate Level of Effort (LOE) for test/script development, test execution, and other activities central to their assigned tasks
- You’ll collaborate with other team members and with staff on other teams and departments
- You’ll represent and advocate for QA with other members of the Product Development team for the purposes of joint triage of defects, reporting test results, and making overall product quality assessments
- You’ll communicate progress and escalates issues to management in a timely manner
- Be expected to maintain awareness of the regulatory and clinical research/pharmaceutical industry environment and, as a result, has the ability to influence internal Business Partners on best quality & compliance practices and to form quality mindset
Qualifications for senior quality assurance specialist
- Excellent ability to make a realistic diagnosis, question the evidence, challenge data from different sources
- Excellent ability to adapt quickly to unexpected situations and reorganize priorities
- Excellent listening skills, interpersonal skills, ability to manage conflict and step back
- Ability to understand local specific environment and culture, curiosity, interest for regulatory trends
- Excellent command of English and synthetic writing skills
- Ready to travel 40% of time
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Senior Quality Assurance Specialist Job Description
Job Description Example
Our company is searching for experienced candidates for the position of senior quality assurance specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior quality assurance specialist
- Responsibility for Calibrated Quality Oversight at the assigned External Partners (ExP) based on the product type, capabilities, quality and compliance performance of the ExP, to assure that goods are produced in conformance to cGMP´s, applicable procedures and in compliance with applicable regulations
- Manages internal initiatives and key projects as assigned, relating to emerging regulatory topics, industry best practices
- Compiles and reviews Testing batch records in accordance to cGXP and internal procedures in an efficient and timely manner
- Evaluate and perform trend analysis and report results for quality metrics
- Assess compliance with cGMP regulations on difficult and complex technical issues
- Perform batch record review, control record review, and product disposition
- Coordinate the shipment of final products with Manufacturing and Materials Management
- Prepare and issue detailed, highly complex reports within the framework of departmental procedures
- Schedule and lead/participate in internal and external audits
- Support the execution of cGMP systems aimed at evaluating and maintaining quality and compliance
Qualifications for senior quality assurance specialist
- Ability to manage both day-to-day operations project work in a fast paced environment
- At least 5 years of experience in a pharmaceutical manufacturing environment with cGMP requirements or other related industry, with strong knowledge of QC laboratory and/or manufacturing systems, preferably with related computer systems administration experience
- Laboratory Technician, BS or MSc in Science, Computer Science or related field
- Proficient in the use of business, scientific and personal computer software and hardware, system security data collection hardware, operating systems and application software
- Very good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred
- Works independently on routine tasks including complex cases, makes decisions for minor issues
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Senior Quality Assurance Specialist Job Description
Job Description Example
Our innovative and growing company is hiring for a senior quality assurance specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior quality assurance specialist
- Leads/mentors Quality Assurance team
- Supports site for regulatory inspections related to automation compliance
- Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success
- Trains user community on the application of best practices and pertinent (Systems Life Cycle) SLC topics
- Develops site procedures and reviews updates to divisional guidelines
- Responds to divisional computer validation initiatives and Quality Alerts
- Responsible for updating and tracking document approval status and updating the Quality Automation Compliance Review / Approval database
- Perform lot file review, which will include batch records and associated documentation
- Establish standard operating procedures and work instructions as required for QA&RA and cross functional activities
- Oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
Qualifications for senior quality assurance specialist
- Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records)
- A minimum of 4-5 years of regulatory affairs/Quality Assurance working experience, mainly for medical devices
- Ability to work within a team environment and build relationships outside of the department outside the company (suppliers, regulatory agencies)
- A minimum of 8 years of work experience in a scientific area, administrative position or related field
- Extensive knowledge of the US and international GLP and GMP regulations, knowledge of 21 CFR Part 11
- Knowledge of applicable computer systems used by Document Control
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Senior Quality Assurance Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior quality assurance specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior quality assurance specialist
- Work with management to establish and maintain job performance and training requirements for each role
- Design, develop, and maintain documentation such as training materials, qualifications / assessments, modules, curriculums, and area records and files
- Generate various training status tracking reports
- Monitor trends and identify potential quality problems within the supply chain and advise on resolution
- Assist with Regulatory and Customer audits as required
- Routinely apply effective and professional communication and organizational skills to coordinate project activities and ensure timely completion of required tasks
- Test plans creation
- Test design preparation
- Running automation testes
- Leads a testing project(s) using the BMO internal testing process and tools
Qualifications for senior quality assurance specialist
- Experience in the clinical (GCP) OR pharmacovigilance (PV) OR computer systems validation (CSV) area is required
- Possesses initiative, self-motivation, enthusiasm and a positive attitude
- Work closely with the Quality and Supply Chain network to ensure the quality performance of the local D&L external partners is consistent across the globe
- Strong demonstrated interpersonal, communication, and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations
- Good analysis, troubleshooting, investigation and communication skills, especially both written and verbal
- Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices and CAPA
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Senior Quality Assurance Specialist Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior quality assurance specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior quality assurance specialist
- Attend, participate, and/or lead team of on-site and/or remote auditors (pull lists, attribute application, etc)
- Apply audit standards and follow directions on properly applying `yes/no questions to determine accuracy
- Investigate, develop and apply changes to the Operations department to the audit documents
- Supports Manager
- Reviews FDA, Health Canada and EMEA websites for relevant and updated regulatory developments
- Assists in creating a continued work culture, closely with the management team, in ensuring that all employees understand the importance of all quality concepts
- Creates and delivers training presentations for Quality Assurance regulations and guidelines , GMP, GxP etc
- Participate in the implementation of Quality Assurance procedures and process improvements to ensure the quality of the product(s)
- Work with manufacturing to determine quality attributes and requirements for incoming, equipment, validation, software, material and process used in production
- Provide day-to-day support and oversight to operations and engineering to address issues and questions in accordance with Quality Systems requirements
Qualifications for senior quality assurance specialist
- Ability to put complex thoughts and issues into writing in such a manner than an educated, but uniformed reader can understand and make decisions based on the written investigation report
- Method competence in QA investigational techniques and risk analysis
- Excellent interpersonal and communication skills and the ability to work with people at all levels
- Self-motivated, flexible and able to work autonomously
- Working knowledge of cGMP, QSR and ISO regulations/standards relating to IVD instrumentation
- Experience of participating in/leading regulatory audits