Specialist, QA CMOLocation Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This position is responsible for performing BioMarin Quality Assurance (QA) review of Contract Manfuacturing Organization (CMO) manufacturing batch records and associated documentation. This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of manufacturing batch records includes verifying conformance to cGMPs, SOPs and batch record process limits
The ideal candidate will have strong organization and communication skills.
The individual is expected to communicate well with CMO/Packaging Ops, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain both at BioMarin and CMOs.
- Perform BioMarin QA review of BioMarin Manufacturing executed batch records and associated documentation for compliance with cGMPs, BioMarin SOPs, and other BioMarin polices and procedures.
- Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.
- Receive, control, scan and archive CMO executed batch records.
- Prepare lot history folders for Drug Product (DP) lots.
- Update QA CMO datases/Oracle EBS
- Obtain data for complaint investigation, etc.
- Other QA CMO duties as assigned.
The scope of this position is limited to performing department tasks in accordance with supervisor’s instructions
- 0-2 years of directly related experience in a GMP Quality or Manufacturing environment.
- Working knowledge of process and desktop computers. Proven comprehension of technical information and regulatory expectations.
- BA or BS in a technical discipline (physical or biological sciences preferred).
- This position does not utilize any specific equipment.
- This position will require interaction with all levels (up to Senior/Executive Management) in Technical Operations, Clinical Operations, Pharm/Tox, Regulatory, R&D, Business Operations, Finance, Information Technology, and Administration.
- This position will not have supervisory responsibilities