Senior Quality Compliance Specialist

The Fountain Group is currently seeking a Senior Quality Compliance Specialist for a prominent client of ours. This position is located in Newbury Park (Thousand Oaks), CA
. Details for the position are as follows:

• Pay: $50-76.42/hr., based on years of experience.
• 12-month assignment with possibility for extension or conversion based on performance and budget.

• Drive analytical method validation/ transfer of laboratory methodologies
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
• Support troubleshooting of analytical methods
• Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• May support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
• Responsible for deliverables to ensure timelines and milestones are met.

• Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements
• Knowledge of analytical methods and operations with strong emphasis in problem‑solving.
• Knowledge about analytical method validation.
• Intermediate statistical knowledge and experience with data analysis
• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods
• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21
  
  CFR, ICH etc.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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