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

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.

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

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

• 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.

• 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
  .