Senior Quality Assurance Compliance Specialist

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Job description

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

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.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA) Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) Amplify's Manufacturing Enablement Center.

About ADOC South San Francisco, CA. AmplifyBios discovery optimization and characterization unit (ADOC) establishes critical product characterization benchmarks, optimizes efficacy, and identifies new targets and strategies for clients preparing to scale up the production of therapeutic candidates. The site also houses GMP manufacturing suites, and quality labs available to clients. Based on broad experience in cell and gene therapy manufacturing, this group seeks to address the widening gap between R&D and manufacturing CMC.

AmplifyBio is seeking to hire a Sr. QA Compliance Specialist to join our growing team

The Sr. QA Compliance Specialist is responsible for the management and execution of the Suppler Quality Management (SQM) and Audit Programs for the New Albany GMP facility. This role will ensure supplier qualifications, external and internal audits are performed in a timely manner to meet quality and business objectives. The ideal candidate is a hands-on leader with experience in GMP regulated environments.

What Youll Do Here:

• Enhance and manage existing procedures for: the selection and management of GMP suppliers and the execution of the audit program (internal, external and client audits).
• Maintain GMP vendor files, Approved Supplier List (ASL) and conduct periodic assessment 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.
• Provides site training on for the supplier and audit programs to ensure process alignment.

We Would Love to Hear From You If:

• A Bachelors degree or higher in a relevant scientific discipline Bioinformatics, Biology, Biochemistry, Chemistry or equivalent education and experience
• A minimum 5+ years of experience in Quality and GxP biotechnology or pharmaceutical environment.
• Must have experience with SQM and/or CQA . However, 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 resolutions skills.
• Ability to apply a risk-based approach related to this role.

At AmplifyBio we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we 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.

Why You Will Love Working Here:
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.

• 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 FLEIXIBLE 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 everyones voice matters.
• We are just getting started! More benefits on the way!
• An Opportunity to Change the World

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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