Quality Control Validation Scientist

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 currently seeking a Quality Control Validation Scientistfor a prominent client of ours. This position is located in Newbury Park (Thousand Oaks) , CA. Details for the position are as follows:

Quality Control Validation Scientist
Location: Newbury Park (Thousand Oaks) , CA
Pay Rate: $80.30-$83.06/hr
Duration: 6 months

Job Description

Support Quality Control activities within the AQC department, including analytical method transfer, validation, and execution in a cGMP environment.

• Drive analytical method validation and transfer for laboratory methodologies, including raw material methods.

• Execute and resolve discrepancies associated with test plans and validation protocols.

• Troubleshoot analytical methods and support issue resolution.

• Maintain laboratory equipment in a validated state and ensure analytical methods meet company and regulatory requirements.

• Generate validation protocols, reports, and technical documentation, including raw material qualification documentation.

• Apply statistical techniques and data analysis to evaluate laboratory results and resolve technical issues.

• Support installation, operational qualification (IOQ), maintenance, and troubleshooting of AQC instrumentation.

• Review and approve applicable life cycle validation documentation.

• Support validation activities for QC/Micro laboratory instruments, equipment, facilities, utilities, and computerized systems.

• Work in laboratory, controlled, and clean-room environments as required.

Education

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

• Advanced degree may substitute for the required analytical development or validation experience.

Required Skills

• Minimum 1 year of analytical development or validation experience in a pharmaceutical, biopharmaceutical, or related manufacturing environment.

• Hands-on experience with analytical method validation and method transfer.

• Experience with cGMP laboratory requirements and unexpected results investigations.

• Knowledge of CGMP, QSR, USP, 21 CFR, and ICH requirements applicable to analytical testing.

• Experience with analytical instrumentation qualification and validation.

• Experience generating and reviewing validation protocols, test plans, and technical reports.

• Intermediate statistical knowledge and experience with laboratory data analysis.

• Experience with QC/Microbiology laboratory instrument qualification and method validation.

• Knowledge of Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.

• Experience with computer system validation (CSV) documentation, including SCADA and MES systems.

Preferred Skills

• Experience with Kneat or other paperless validation software used in life sciences.

• Experience reviewing and approving life cycle validation documentation.

• Experience with validation of equipment, facilities, and utilities within biopharmaceutical manufacturing facilities.

• Experience with SCADA/MES validation.

• Experience supporting raw material qualification for pharmaceutical or biopharmaceutical products.

• Proficiency with Microsoft Office.