Quality Control Validation Scientist
Katalyst CRO · Thousand Oaks, CA · 2 mo ago
On-siteQuality AssuranceContract
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.
- 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.
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.
- 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.
- Able to complete tasks with minimal direction, demonstration of basic project management skills.
- Able to multitask in a highly dynamic and diverse environment.
- Attention to detail, good organization, and time management skills to meet deadlines.
- Proficient in Microsoft Office.
- Strategically and business-oriented thinking.