Quality Control Validation Scientist

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.

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. 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.

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. Able 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.