QC Analytical Scientist
Title: QC Analytical Scientist
Location: Thousand Oaks, CA
Pay: $55-62/hr
Contract: 6+ months
Job Summary
As a QC Analytical Scientist, you will support various Quality Control activities within the AQC department. Key responsibilities are to transfer and execute analytical methods, including raw materials, for use in a cGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).
Job 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.
- Responsible for deliverables to ensure timelines and milestones are met.
- Other duties as assigned.
Education & Qualifications
- Bachelor’s Degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
- Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
- The overall physical exertion of this position requires light to medium work.
- Normal office and laboratory environment.
- May need to work in controlled or clean room environments requiring special gowning.
- May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
- Able to work more than 8 hours a day or 40 hours a work week as needed.
Preferred:
- Experience with the KNEAT Program.