Senior Quality Assurance Specialist - Investigations

Andelyn Biosciences, Inc • Columbus, OH

1h

About The Position

The Senior QA Specialist, QA Investigations/CAPA is an individual contributor responsible for technical quality compliance activities in accordance with GxP regulations and internal SOPs. The role ensures deviations are thoroughly investigated, root causes are determined, and risk-appropriate corrective actions are identified and implemented. It also oversees and communicates critical deviation and CAPA metrics and provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to detect process shifts.

The specialist supports investigation and CAPA processes, partners with subject matter experts, and provides oversight of trend and lifecycle review activities. The role also serves as the subject matter expert and trainer for the TrackWise Investigation/CAPA module, authors and reviews quality documentation, and supports cross-functional collaboration and continuous improvement.

Requirements

• Minimum of 5 years of experience in the GMP, biopharmaceutical, biotechnology, or FDA-regulated industry.
• 3–5 years of hands-on QA experience in a pharmaceutical environment.
• Bachelor’s degree in a technical or scientific discipline, or equivalent.
• Operational knowledge of cGMP regulations and guidelines, including U.S. Code of Federal Regulations 21 CFR Part 11 and Parts 210 and 211.
• Demonstrated project management abilities, including leading and managing several projects, meeting deadlines, and applying critical thinking to solve problems.
• Excellent verbal and written communication skills at all levels of the organization; technical writing is required.
• Experience authoring and executing quality documentation, including SOPs, CAPAs, and investigations.
• Experience interacting with FDA and EMA inspections.
• Strong cross-functional teamwork experience and the ability to influence, negotiate, manage conflict, and collaborate.
• Demonstrate a can-do attitude.
• Proficiency using computers as a business tool, including Microsoft Word, Excel, and PowerPoint.

Nice To Haves

• Cell and gene therapy experience.
• Knowledge of application software such as TrackWise and SAP.

Responsibilities

• Oversee and support prompt evaluation, investigation, closure, and follow-up of unplanned events, and identify opportunities for continuous improvement.
• Work with subject matter experts to ensure thorough root cause analyses, assess impact to SISPQ, and ensure root causes are addressed through appropriate corrective and preventive actions.
• Establish appropriate CAPA ownership and timelines based on the risk associated with an event or issue.
• Assess final supporting documentation for adequacy when completing or closing CAPAs, and conduct effectiveness checks for high-risk events.
• Communicate critical deviation and CAPA metrics and chair the Investigation Review Board meeting.
• Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
• Serve as the subject matter expert and trainer for the TrackWise Investigation/CAPA module.
• Prepare and report quality metrics so upper management is aware of trends and ongoing activities related to investigations and CAPAs.
• Ensure documentation is maintained in accordance with internal procedures and regulatory requirements.
• Assess the accuracy and compliance of procedures as an SOP author, reviewer, and approver, and work with cross-functional approval panels on timely, accurate document revisions.
• Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Perform other related assignments and duties as required and assigned.

Benefits

• Competitive compensation.
• Medical, dental, and vision insurance eligibility beginning on day one; basic vision coverage is 100% company-paid.
• 160 hours of paid time off annually.
• 11 company-paid holidays and 2 floating holidays annually.
• Company-paid life insurance.
• 401(k) match.
• Company-paid short- and long-term disability.
• Four weeks of paid parental leave for birth and adoption.
• Adoption assistance.
• Tuition reimbursement and student loan repayment assistance.
• Company-paid LinkedIn Learning access.
• Employee Assistance Programs.
• Flexible work options, role specific.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior