Senior Quality Assurance Operations Specialist
5 days ago
We are seeking a highly experienced and skilled Quality Assurance Operations professional to join our team at AmplifyBio. As a Quality Assurance Operations Specialist, you will play a critical role in ensuring the quality and compliance of our cell and gene therapy manufacturing operations.
Key Responsibilities- Review and approve GMP documentation, including SOPs, batch records, deviations, and investigations
- Manage and trend lot/product disposition activities
- Provide guidance on quality topics to foster a quality culture and quality mindset
- Conduct compliant investigations and review/approve investigations as needed
- Provide direction to Quality and non-Quality personnel performing analytical data reviews and general analytical support
- Support finished product shipments to clinical sites in conjunction with logistics/clinical and supply chain functions
- Support Tech Transfer activities for new projects
- Participate in quality audits in support of GMP operations and regulatory requirements
- Partner with Program Management, Manufacturing, Quality Control, Supply Chain, and attend meetings in support of relevant cell-based manufacturing programs and activities
- Bachelor's degree or higher in a relevant scientific discipline (Bioinformatics, Biology, Biochemistry, Chemistry, or other relevant area)
- Minimum of 2/4/8 years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities
- Understanding through prior experience of GMP regulation and guidelines related to the conduct of early phase clinical programs (21 CFR Part 210 and 211)
- Must have extensive cGMP quality system knowledge and experience
- Experience using and/or managing eQMS, such as Veeva
- Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills
- Strong teamwork, leadership, organization, and communication skills
- Experience in cell and gene therapy is a plus
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 are committed to growing and empowering an inclusive community within our company and industry. Therefore, 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.
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