Senior Quality Assurance Compliance Specialist

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),

ASET

(West Jefferson, OH), and

AMEC

(New Albany, OH).About ADOC :

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.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 Supplier Quality Management (SQM) and Audit Programs for the New Albany GMP facility. This role will ensure supplier qualifications and 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 You’ll Do Here: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.We Would Love to Hear From You If:A Bachelor's degree or higher in a relevant scientific discipline (Bioinformatics, Biology, Biochemistry, Chemistry or equivalent education and experience).A minimum of 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 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 detail, and excellent problem resolution 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 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:Health, Dental, and Vision insurance that starts on your first day at

AmplifyBio!Competitive Compensation PackageWe take work-life balance seriously and back it up with a FLEXIBLE PTO program!Generous paid parental leaveWellness and Self-Care Programs401(k) matchTuition ReimbursementEAP/work-life support systemA fun work environment where everyone's 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.

#J-18808-Ljbffr