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Documentation Specialist
1 month ago
Job Title: Specialist, QA Operations (Biotech/ Pharma Background)
Department: QA Operations Protein
Location: Digital Dr Novato, CA 94949, 100% Onsite
Pay Rate: Up to $35/ HR
2-Month W2 Contract with potential to extend
Overview: The Specialist, QA Operations will report to the Quality Assurance Supervisor/Manager/Senior Manager. This role is responsible for the quality oversight of one or more processes related to the production, assessment, and release of products manufactured at our global biotechnology client's Novato facilities.
We are looking for biotech/ pharma/ MA tech backgrounds, this is a more sedentary role but requires that background knowledge
Key Responsibilities:
- Provide quality oversight of manufacturing operations to ensure adherence to Good Manufacturing Practices (GMP).
- Directly observe manufacturing operations for GMP compliance.
- Review GMP documentation from manufacturing and Quality Control (QC), including logbooks, batch records, and test records.
- Issue Production Batch Records to Manufacturing.
- Scan and archive executed production batch records.
- Ensure compliance with company policies/procedures, regulatory licenses, industry standards, and GMP regulations.
- Maintain working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions are a plus).
- Revise QA-related procedures as needed.
Skills:
- Must have Pharmaceutical experience 1+ years
- Strong attention to detail.
- Proficiency in MS Office.
- Ability to operate basic office equipment (e.g., scanners, printers).
Education:
- Associate degree or higher.
Please submit your resume in Word or PDF for consideration.