Demo

Quality Assurance Manager

Meet
Los Angeles, CA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/28/2025

Working Schedule : Tuesday-Saturday

Employment Type : W-2 only

Job Summary :

As a Quality Assurance Manager, you will play a vital role in ensuring the compliance and integrity of our GMP Quality Assurance processes. This position involves overseeing critical functions such as Asset Management, Batch Records, Change Management, Deviation and CAPA, support for GMP Cleanroom operations, Lot Disposition, Quality Control (QC) Data, Quality Risk Management (QRM), and handling of Raw Materials.

We are looking for a dedicated professional with substantial experience in GMP biopharmaceutical operations, clinical manufacturing, and quality management systems. If you thrive in a dynamic environment and are passionate about quality assurance, we encourage you to apply!

Key Responsibilities :

  • Drive continuous improvement initiatives for GMP processes and develop or update Standard Operating Procedures (SOPs).
  • Actively participate and represent QA on project-specific teams.
  • Review and approve completed batch records, Change Management documents, and records of Deviation and CAPA.
  • Provide quality assurance support for cleanroom operations, including changeover procedures, line clearance, and responding to events.
  • Review final product lot files to determine lot disposition.
  • Engage in Quality Risk Management (QRM) activities and perform risk assessments.
  • Evaluate incoming raw materials and validate their specifications.
  • Contribute to the writing and revision of SOPs as required.
  • Assist with routine QA operations and support as necessary.

Qualifications :

  • BSc degree with a minimum of 7 years’ relevant experience in biology, biochemistry, chemical engineering, bioengineering, or a related field, OR
  • MSc degree with at least 4 years of applicable experience.
  • A minimum of 6 years in GMP biopharmaceutical operations, including at least 4 years in a Quality role.
  • Proven experience in clinical manufacturing and quality management systems, particularly in handling deviations, CAPAs, and change management.
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