Senior Quality Assurance Compliance Specialist
4 days ago
AmplifyBio is a leading contract research organization that provides a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.
Job SummaryWe are seeking a Senior Quality Assurance Compliance Specialist to join our growing team at AmplifyBio. The successful candidate will be responsible for the management and execution of the Supplier Quality Management (SQM) and Audit Programs for our New Albany GMP facility.
Key Responsibilities- Enhance and manage existing procedures for the selection and management of GMP suppliers and the execution of the audit program.
- Maintain GMP vendor files, Approved Supplier List (ASL), and conduct periodic assessments to ensure all vendor certification documents, licenses, and statements are current.
- Participate in drafting quality technical agreements as required.
- Co-manage the Material Review Board with QA Ops.
- Develop and manage the supplier and internal audit schedule, generate audit plans, and conduct routine quality audits of GMP suppliers/service providers and internal QMS.
- Maintain all audit reports, audit responses, and pertinent corrective actions up to date.
- Conduct follow-ups for internal and supplier audits corrective actions to ensure closure.
- Support QA Operations team to investigate product quality complaints, quality events, incidents, and CAPAs associated with materials or supplier services.
- Develop and report on KPIs/metrics for SQM and Audit Program to identify areas for improvement.
- Provide site training on the supplier and audit programs to ensure process alignment.
- Bachelor's degree or higher in a relevant scientific discipline (Bioinformatics, Biology, Biochemistry, Chemistry, or equivalent education and experience).
- Minimum 5+ years of experience in Quality and GxP biotechnology or pharmaceutical environment.
- Must have experience with SQM and/or CQA. SQM and/or CQA certifications are a plus.
- Understanding through prior experience of GMP regulation and guidelines related to the conduct of early phase clinical programs such as 21 CFR Part 210 and 211.
- Must have prior supplier qualification and auditing experience.
- Ability to work with minimal supervision.
- Strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem-resolution skills.
- Ability to apply a risk-based approach related to this role.
- Competitive compensation package.
- Health, dental, and vision insurance that starts on your first day at AmplifyBio.
- Flexible PTO program.
- Generous paid parental leave.
- Wellness and self-care programs.
- 401(k) match.
- Tuition reimbursement.
- EAP/work-life support system.
- A fun work environment where everyone's voice matters.
AmplifyBio is an equal opportunity employer and values diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
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