Quality Associate, Donor Charts Team - Berkeley Biologics, LLC
Richmond, CA
About the Job
Berkeley Biologics, founded in 2023, manufactures high-quality, cost-effective, clinically relevant human cell/tissue products. The company offers a broad variety of allografts for bone, wound care and soft tissue applications. Berkeley Biologics is a licensed Tissue Bank that is accredited by the AATB.
The Quality Associate in Donor Charts Team will perform a wide variety of activities associated with donor records management to ensure compliance with Berkeley Biologics requirements, FDA regulations/guidance documents and AATB Standards. This position will collaborate with operations to ensure compliance with applicable regulations and accomplish company goals of restoring health and mobility to the greatest number of patients possible.
This position is onsite in our Richmond, CA facility and reports to the Director, Quality Assurance and Regulatory.
Responsibilities:
- Performs technical review of donor history information for completeness and accuracy and ensures donor is in compliance with SOPs and applicable standards/regulations
- Prepares finalized donor chart information for donor eligibility review
- Extracts information from donor charts and enters information into the appropriate Berkeley Biologics systems
- Communicates information to other departments with the ability to act as the primary departmental point of contact
- Communicate information with procurement agency partners as appropriate
- Investigate any non-conforming events identified during record review, CAPA investigations and complaint investigations
- Maintains confidentiality of all records and information, which pertains to donors, families, employees, the organization and related areas
- Rotate on-call schedule 24/7 with other members of the team
Experience and Skills:
- Minimum 2 year of experience in a regulated industry required
- Experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred
- Ability to understand and follow policies and procedures based on FDA, AATB, and OSHA regulations
- Ability to read and interpret complex medical documents, procedures, standards, regulations, etc.
- Ability to prioritize projects and adapt to shifting priorities
- Strong knowledge of standard PC-based Microsoft Office applications
- Strong preference for AATB Certified Tissue Bank Specialists
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)
Pay range $68,640 - $75,000