Senior Quality Systems Specialist
Senior Quality Systems Specialist
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Job Description
About this opportunity :
The Senior Quality Systems Specialist QA will be responsible for performing QA review and approval of Change Controls Deviations CAPAs Batch Records and associated GMP documentation to ensure compliance with applicable regulatory standards (FDA EMA ICH). This role serves as a Subject Matter Expert (SME) for Change Management processes across multiple sites (Milford Irvine and Cincinnati) and requires hands-on knowledge of Veeva and TrackWise system integration).
Key Responsibilities:
- Perform QA review and approval of Change Control Requests (CCRs) and Change Control Plans (CCPs).
- Provide workflow support and Q&A to cross-functional users across Avecia sites.
- Deliver monthly Change Control training sessions and maintain OJT documentation.
- Host weekly Change Management Review Meetings to address newly proposed changes and track CCRs >1 year.
- Maintain ownership of change management SOPs.
- Prepare CCRs/CCPs for internal and external audit requests.
- Compile and report weekly CCR metrics to QA leadership.
- Act as QA Reviewer for Deviations and serve as CAPA Coordinator.
- Ensure thorough root cause evaluation and implementation of effective corrective actions.
- Lead/Track the Deviation review board.
- Review and approve controlled documents in accordance with document lifecycle procedures.
- Maintain compliance with applicable regulatory and company documentation standards.
- Represent QA in QA Group Quality Compliance Oversight and site-wide meetings.
- Actively collaborate with QC Manufacturing Regulatory and Supply Chain functions.
- Experience with Veeva QMS and/or TrackWise systems required.
- Familiarity with SAP SmartSolve and electronic batch record (EBR) systems.
- Ability to navigate integrate and troubleshoot cross-platform data for QA use cases.
Required Skills/Abilities:
- Bachelors degree in Chemistry Biology Pharmaceutical Sciences or related discipline.
- 5 years in GMP Quality Assurance within the pharmaceutical or biotech industry.
- Experience in Quality Systems like Deviation/CAPA/Out of Specification/Change Control is essential.
- SME-level understanding of Veeva and/or TrackWise for Change Control and CAPA processes.
- Proven ability to manage cross-site QA functions timelines and communication.
- Strong written and verbal communication skills.
- Prior QA ownership of SOPs and internal audit responses
- Comfortable leading training sessions and SME discussions during audits.
- Experience supporting regulatory inspections and customer audits.
- Familiarity with Powerbi preferred.
- Familiarity with oligonucleotide APIs and CDMO operations
Required Experience:
Senior IC
Employment Type
Full-Time
