Specialist, QA Operations
Specialist, QA Operations
Location: Novato, CA (100% on-site)
12-Month Contract Assignment (Potential to extend / covert)
Pay: 33-35 / HR
Our client, a global leader in biotechnology and innovation of therapies for rare and genetic diseases and life-threatening conditions is looking for a Specialist, QA Operations to join their team. This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products produced in Novato manufacturing facilities.
Responsibilities:
Provide quality oversight of one or more portions of operations including, but not limited to;
- Direct observation of manufacturing operation for adherence to GMP.
- Review of GMP documentation from manufacturing and/ or QC, which can include log books, batch records and test records.
- Issuance of Production Batch Record to Manufacturing
- Scanning and archiving executed production batch records
- Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.
- Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
- Revise QA related procedures as needed.
Education and Qualifications:
- Associates or Bachelors Degree
- Experience within pharmaceutical / biotech industry is a plus!
- Ability to operate basic office equipment (Scanners, Printers, MS Office, etc.)
Please submit your resume in Word or PDF format to be considered.