Quality Assurance Specialist

4 weeks ago


Fremont, United States Compunnel Inc. Full time

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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