Senior Quality Control Specialist

5 days ago

Thousand Oaks, California, United States Randstad Full time
Quality Control Analyst Job Description

We are seeking a highly skilled Quality Control Analyst to join our team at Randstad. As a Quality Control Analyst, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities:

  • Conduct biological or chemical and physical analyses on raw materials, in-process samples, final product samples, and other samples collected from manufacturing areas.
  • Apply advanced laboratory skills to perform complex assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
  • Wet Chemistry, knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals.
  • Raw Materials, Product Release, and Stability Monitoring Testing (Routing and on-demand).
  • Ordering, Troubleshooting, Service Catalog Ordering, Schedule Repairs and Preventive Maintenance of HPLC/Raw Material Instruments.
  • Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and CGMP regulations.
  • Investigate complex nonconformances and write exception documents or lead others in writing investigation.
  • Column/Control/Standard Qualification for release testing.

Requirements:

  • Bachelor's Degree in Chemistry, Microbiology or Biological Sciences strongly preferred. With 3+ years' industry experience.
  • Experienced in Wet Chemistry - deep understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices.
  • Familiar with the USP, EP, and JP Pharmacopeia and troubleshoot issues that arise during experimentation.
  • HPLC Testing, Raw Material, Elisa (preferred), LIMs.
  • Endotoxin Testing, Bioburden testing, and/or TOC/Conductivity testing.
  • Knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
  • Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus.

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