QC Validation Scientist - cGMP Analytical Expert

The Fountain Group; Thousand Oaks (CA); On-site; USD 111,000 - 114,000; Full time

Job summary

The Fountain Group is seeking a Quality Control Validation Scientist for a key client in Newbury Park, CA. The role focuses on driving analytical method validation and transfer, ensuring cGMP compliance, and generating comprehensive validation documentation.

You will evaluate data, troubleshoot methods, and support IQ/OQ/PQ activities across QC labs. Applicants should have a Bachelor's in a life sciences field, hands-on validation experience, and familiarity with CGMP/USP/ICH requirements.

Qualifications

• Bachelor's degree in a Life Sciences field or equivalent.
• Hands-on experience with analytical method validation and transfer.
• Experience in a cGMP environment and knowledge of CGMP/USP/ICH requirements.
• Experience generating validation protocols, reports and technical documentation.
• Strong data analysis and statistical skills.

Responsibilities

• Drive analytical method validation and transfer for laboratory methodologies.
• Execute and resolve discrepancies in test plans and validation protocols.
• Troubleshoot analytical methods and support issue resolution.
• Maintain validated lab equipment and ensure regulatory compliance.
• Generate validation protocols, reports, and technical documentation.

Skills

Analytical method validation

Method transfer

cGMP laboratory requirements

Laboratory data analysis

Analytics instrumentation qual/val

Validation protocols/reports

IQ/OQ/PQ knowledge

Education

Bachelor's degree in Biotechnology/Microbiology/Pharmacy/Chemistry

Advanced degree may substitute experience

Tools

Kneat

SCADA

MES

Microsoft Office

Job description

The Fountain Group is seeking a Quality Control Validation Scientist for a key client in Newbury Park, CA. The role focuses on driving analytical method validation and transfer, ensuring cGMP compliance, and generating comprehensive validation documentation.

You will evaluate data, troubleshoot methods, and support IQ/OQ/PQ activities across QC labs. Applicants should have a Bachelor's in a life sciences field, hands-on validation experience, and familiarity with CGMP/USP/ICH requirements.