Job Description: 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).
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.
Requirements: - 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.
- bility to complete tasks with minimal direction, demonstration of basic project management skills.
- bility to multi-task in a highly dynamic and diverse environment.
- ttention to detail, good organization, and time management skills to meet deadlines.
- Proficient in Microsoft Office.
- Strategically and business-oriented thinking.
Physical Demand: - The overall physical exertion of this position requires light to medium work.
- Working Environment.
- 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.
- ble to work more than 8 hours a day or 40 hours a work week as needed.
Additional Notes: - 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.
