Quality Control Validation Specialist C2C Thousand Oaks, California

Title:

Quality Control Validation Specialist

Location:

Thousand Oaks, California

Analytical method validation/ transfer of laboratory methodologies, strong technical writing skills, experienced in reviewing and approving Life Cycle Validation Documents. Familiar with paperless validation software for life sciences.

Commissioning, installation, operational and performance qualification protocols and reports for equipment, facilities & utilities at biopharmaceutical manufacture plant. Computer system validation protocols and reports, including SCADA and MES. QC/Micro laboratory instrument qualification and method validation.

• Drive analytical method validation/transfer of laboratory methodologies
• Support the execution, issue resolution, and approval of test plans/protocols
• Support troubleshooting of analytical methods
• Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements
• Generate protocols and reports and other technical documents as required; support raw material qualification for new products
• Use sound scientific principles and statistical techniques to solve problems and make recommendations
• Support installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group

• Strong technical writing skills; able to generate technical documents and reports that meet company and regulatory requirements
• Knowledge of analytical methods and operations with strong emphasis in problem solving
• Knowledge of analytical method validation
• Intermediate statistical knowledge and experience with data analysis
• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation
• Basic knowledge of regulatory requirements concerning analytical instrumentation and test methods
• Substantial knowledge and understanding of regulatory standards requirements, e.g., CGMP, QSR, USP, 21
  
  CFR, ICH
• Proficient in Microsoft Office
• Strategically and business-oriented thinking
• Experience in reviewing and approving Life Cycle Validation Documents
• Familiar with paperless validation software for life sciences
• Commissioning, installation, operational and performance qualification protocols and reports for equipment, facilities & utilities at biopharmaceutical manufacture plant
• Computer system validation protocols and reports, including SCADA, MES
• QC/Micro laboratory instrument qualification and method validation

• Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy, Chemistry or equivalent
• Minimum of 7 years of analytical development or validation experience in pharmaceutical, biopharmaceutical or related manufacturing environment, or an advanced degree
• Nice to have the KNEAT Program, not required