Quality Assurance Specialist
4 weeks ago
We are seeking a detail-oriented and experienced Quality Assurance Specialist - Batch Record Reviewer II to join our team. The ideal candidate will provide independent quality assurance oversight in areas responsible for adhering to current Good Manufacturing Practices (cGMPs).
Job Tittle: Batch Record Reviewer II
Duration: 06 Months (Possible Extension)
Location: Fremont, CA
Job Duties:
- Provide quality assurance oversight in cGMP areas, including Quality Control Systems
- Identify, investigate, and resolve quality-related events impacting products and processes
- Ensure adherence to SOPs, proper change control, CAPA/Deviation management, and risk management
- Make critical decisions impacting manufacturing operations and equipment/system release
- Oversee complex Minor and Major Change Controls
- Perform technical reviews of cGMP documentation
- Verify specifications and requirements are met before releasing to the next step
- Analyze and report findings to appropriate departments
Required Skills:
- Team Lead or Supervisory experience
- Strong attention to detail and problem-solving skills
- Ability to prioritize and work under pressure in a fast-paced environment
- Proficiency in MS Office (Word, Excel) and SAP
- Technical knowledge of manufacturing systems, methods, and procedures
- Excellent written and verbal communication skills
- Understanding of Manufacturing processes
Education:
- Bachelor's degree in Life Sciences or Engineering
If you're passionate about quality assurance in a cGMP environment and have the skills to make critical decisions independently, we want to hear from you
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