Senior Quality Assurance Compliance Specialist
5 days ago
We are seeking a highly skilled Senior Quality Assurance Compliance Specialist to join our team at AmplifyBio. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.
Key Responsibilities- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Conduct supplier qualification and auditing to ensure the quality and reliability of our suppliers.
- Manage and maintain vendor files, approved supplier lists, 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 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.
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. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.
We are an equal opportunity employer and value 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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