Quality Assurance Analyst

2 weeks ago


Fremont, California, United States Compunnel Inc. Full time

We are looking for a meticulous and knowledgeable Quality Assurance Specialist - Batch Record Reviewer II to enhance our quality assurance efforts. The successful candidate will be responsible for providing independent oversight in compliance with current Good Manufacturing Practices (cGMPs).

Position Title: Batch Record Reviewer II

Contract Duration: 06 Months (Potential for Extension)

Key Responsibilities:

  • Deliver quality assurance oversight in cGMP environments, focusing on Quality Control Systems.
  • Detect, investigate, and resolve quality-related incidents affecting products and processes.
  • Ensure compliance with Standard Operating Procedures (SOPs), effective change control, and management of CAPA/Deviations and risks.
  • Make significant decisions that influence manufacturing operations and the release of equipment/systems.
  • Supervise intricate Minor and Major Change Controls.
  • Conduct thorough technical evaluations of cGMP documentation.
  • Confirm that specifications and requirements are satisfied prior to progression to subsequent stages.
  • Analyze findings and communicate results to relevant departments.

Essential Qualifications:

  • Experience in a Team Lead or Supervisory role.
  • Exceptional attention to detail and adept problem-solving abilities.
  • Capability to prioritize tasks and perform under pressure in a dynamic environment.
  • Proficient in MS Office (Word, Excel) and SAP.
  • Technical expertise in manufacturing systems, methodologies, and protocols.
  • Outstanding written and verbal communication skills.
  • Comprehensive understanding of manufacturing processes.

Educational Background:

  • Bachelor's degree in Life Sciences or Engineering.

If you possess a passion for quality assurance within a cGMP framework and the ability to make independent critical decisions, we encourage you to consider this opportunity.



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