Sr./Specialist, Quality Assurance Operations

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 AMEC New Albany, OH: AmplifyBio’s Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

AmplifyBio is seeking to hire a Senior/Specialist, Quality Assurance Operations to join our growing team!!! 

The ideal candidate is an experienced within Quality Assurance Operations with a track record of success in GMP environments who understands biologics processes (i.e. cell & gene therapy, aseptic environments, reagent control, contamination control). 

What You’ll Do Here: 

• Review and approve all GMP documentation including SOPs, batch records, deviations and investigations, QC testing, study reports, validation/qualification protocols and summary reports, etc.
• Provide document review and feedback for CAL/PM program and Environmental Monitoring for the site.
• Manage and trend lot/product disposition activities. 
• Provide training and guidance on Quality topics to foster a quality culture and quality mindset (i.e. Good Documentation Practices).
• Provide compliant investigations, review and approve investigations as needed.
• Provide overall direction to Quality and non-Quality personnel performing analytical data reviews and general analytical support. 
• Support finished product shipments to clinical site 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 manufacturing programs and activities.
• Present data during department and cross-functional meetings as needed.
• Perform other activities as 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 other relevant area.
• A minimum of 2 - 4+ 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 such as, 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 & gene therapy is a plus.

At AmplifyBio, we're 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.