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Quality Assurance Manager
2 months ago
We are seeking a highly skilled Quality Assurance Manager - Supplier Quality to join our team at AmplifyBio.
This is a critical role that 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- Develop and/or enhance existing procedures for the selection and management of GMP suppliers, qualification of raw materials, 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.
- Draft quality technical agreements as required.
- Co-manage the Material Review Board with QA Ops leadership.
- 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 KPIs for SQM and the audit program, assist Supply Chain with KPIs related to material qualification and release.
- Work with QA Training Admin to expand and perform site training for 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 6 years of experience in Quality within a GxP biotechnology or pharmaceutical environment.
- Documented experience with Supplier Quality Management and Internal/External Auditing. SQM and/or CQA certifications are a plus.
- Ability to apply GMP regulation and guidelines related to supplier management, such as 21 CFR Part 210 and 211.
- Ability to work with minimal supervision.
- Experience managing a team of direct reports.
- 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.
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety, efficacy, and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio.
- Competitive Compensation Package.
- We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.
- 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.
- We are just getting started - More benefits on the way.
- An Opportunity to Change the World.
