Sr. QA 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 company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates.
The platforms and domain expertise at our San Francisco site fills the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream.
We partner with our clients, leveraging state of the art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.
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. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. 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.
AmplifyBio’s next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in South San Francisco, CA.
AmplifyBio is seeking to hire a Senior Quality Assurance 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 SSF 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 You’ll 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.
- Perform other activities are required based on company needs.
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 5+ years of experience in Quality and GxP biotechnology or pharmaceutical environment.
- 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.
- SQM and/or CQA certifications are a plus
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. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone — including women, people of color, individuals with disabilities and those in the LGBTQIA+ community — to apply for our available positions, even if they don’t necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do.
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. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required.
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 generous PTO
- Life and AD&D insurance
- Supplemental insurance
- LiveHealth Online
- Smart Shopper (helps you shop for better medical care and earn cash rewards while you save)
- 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!!!