USA - 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:
 

Job Description

Job Title: Quality Control Validation Scientist
Location: Newbury Park (Thousand Oaks), CA
Pay Rate: $64.23–$66.45/hr
Duration: 8 months

• Execute and transfer analytical methods for QC testing in a cGMP environment.

• Drive analytical method validation and transfer activities.

• Troubleshoot analytical methods and resolve testing discrepancies.

• Generate and review validation protocols, test plans, reports, and technical documentation.

• Support raw material qualification for new products.

• Maintain laboratory equipment in a validated state.

• Support IQ/OQ, instrument maintenance, and troubleshooting.

• Apply statistical techniques and data analysis to analytical and validation activities.

• Support validation deliverables, timelines, and project milestones.

Education

• Bachelor’s degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or equivalent.

• Minimum 1 year of analytical development or validation experience in a pharmaceutical, biopharmaceutical, or related manufacturing environment; advanced degree may substitute.

Required Skills

• Analytical method validation and transfer

• cGMP laboratory practices

• Analytical method troubleshooting and unexpected results investigation

• Statistical analysis and data interpretation

• IQ/OQ/PQ protocols and reports

• QC laboratory instrumentation qualification

• 21 CFR, ICH, USP, and QSR regulatory requirements

• Technical documentation, validation protocols, and reports

• Pharmaceutical/biopharmaceutical QC or analytical development experience

Preferred Skills

• KNEAT or other paperless validation software

• Lifecycle validation documentation

• Equipment, facilities, and utilities qualification

• Computer System Validation (CSV)

• SCADA/MES validation

• QC/Microbiology laboratory instrument qualification

• Method validation for QC/Microbiology laboratories

• Biopharmaceutical manufacturing facility validation experience

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