Quality Control Validation Scientist

Quality Control Validation Scientist
Thousand Oaks CA
Duration: 12 Months

Candidate MUST HAVE:

• Analytical method validation/ transfer of laboratory methodologies
• Strong technical writing skills
• Experienced in reviewing and approving Life Cycle Validation Documents including:
  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

Responsibilities:
Drive analytical method validation/ transfer of laboratory methodologies
Support the execution and issue resolution (e.g. discrepancies) and completion 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.
Responsible for protocol and report generation and other technical documents as required. This may include supporting raw material qualification for new products
Use sound scientific principles and statistical techniques to solve problems and make recommendations.
May Support the installation operational qualification (IOQ) maintenance and troubleshooting of instrumentation in the AQC group.

Qualifications:
Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements
Knowledge of analytical methods and operations with strong emphasis in problem-solving.
Knowledge about 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 about regulatory requirements concerning analytical instrumentation and test methods
Substantial knowledge and understanding in terms of regulatory standards requirements e.g. CGMP QSR USP 21CFR ICH etc.
Proficient in Microsoft Office.
Strategically and business-oriented thinking

Education-Experience:
Bachelors 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
Experienced in reviewing and approving Life Cycle Validation Documents including:
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.