Quality Control Validation Scientist

The Fountain Group is currently seeking a Quality Control Validation Scientist for 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 . #J-18808-Ljbffr The Fountain Group