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Senior Quality Assurance Specialist
2 months ago
AmplifyBio is a leading contract research organization that offers a comprehensive range of services, including discovery stage R&D work and manufacturing services for cell, gene, and mRNA-based therapeutics.
Our organization is comprised of three distinct business units: ADOC, ASET, and AMEC, each with its own unique strengths and expertise.
About the RoleThis position plays a critical role in ensuring the quality and compliance of our cell and gene therapy manufacturing processes.
The successful candidate will be responsible for reviewing and approving GMP documentation, including SOPs, batch records, deviations, and investigations.
Key responsibilities include:
- Reviewing and approving GMP documentation to ensure compliance with regulatory requirements
- Managing and trending lot/product disposition activities to ensure quality and compliance
- Providing guidance on quality topics to foster a quality culture and quality mindset
- Investigating and resolving quality issues in a timely and effective manner
- Supporting finished product shipments and tech transfer activities
- Participating in quality audits and regulatory inspections
In addition to the key responsibilities listed above, senior roles will also be responsible for:
- Managing daily QA operations at AMEC's site
- Providing coaching and mentoring to junior staff
- Defining quality metrics and analysis trends
- Maintaining tracking databases associated with data review and lot disposition activities
To be successful in this role, the ideal candidate will possess:
- A Bachelor's degree or higher in a relevant scientific discipline
- Minimum of 2/4/8+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities
- Understanding of GMP regulation and guidelines related to the conduct of early phase clinical programs
- 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
AmplifyBio offers a competitive compensation package, flexible PTO policy, generous paid parental leave, wellness and self-care programs, 401(k) match, tuition reimbursement, and EAP/work-life support system.
We are an equal opportunity employer and value diversity at our company. We are committed to growing and empowering an inclusive community within our company and industry.
