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Senior Quality Compliance Specialist
Job in
Newbury Park, Ventura County, California, 91320, USA
Listed on 2026-03-04
Listing for:
The Fountain Group LLC
Contract
position Listed on 2026-03-04
Job specializations:
-
Healthcare
Data Scientist -
Quality Assurance - QA/QC
Job Description & How to Apply Below
Location: Newbury Park
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.
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Position Requirements
10+ Years
work experience
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