QC Validation Scientist - Contract - Thousand Oaks, CA
Advance quality excellence by driving analytical method transfer and validation in a cGMP environment.
探花合集 is seeking a QC Analytical Scientist to join our client's team in the US. In this role, you will support various Quality Control activities within the AQC department.
Primary Responsibilities:
The successful candidate will 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).
Skills & Requirements:
- 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.
- Ability to complete tasks with minimal direction, demonstration of basic project management skills.
- Ability to multi?task 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
Education and/or experience
- 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.
Physical Demand
- The overall physical exertion of this position requires light to medium work.
The QC Validation Scientist's responsibilities will be:
- 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.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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