Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
Minimum 1 year of analytical development/validation experience in pharmaceutical or biopharmaceutical environments or an advanced degree.
Strong technical writing skills for generating required documentation compliant with regulations.
Knowledge of analytical methods and problem-solving techniques.
Familiarity with analytical method validation and statistical analysis.
Understanding of cGMP regulations and lab-related quality standards.
Project management skills and ability to work independently with attention to detail.
Responsibilities
Drive the validation and transfer of analytical laboratory methods.
Resolve issues and approve test plans/protocols in the analytical quality control process.
Troubleshoot analytical methods to ensure accuracy and reliability.
Maintain laboratory equipment in a validated state per regulatory requirements.
Generate protocols, reports, and other technical documents for compliance purposes.
Apply scientific and statistical principles to solve quality control problems.
Support the installation and qualification of instrumentation in the analytical quality control group.
Benefits
Opportunity to work in a cGMP environment, enhancing compliance and operational experience.
Exposure to a variety of analytical methods and problem-solving scenarios.
Collaboration with a cross-functional team in a dynamic work environment.
Potential for professional development through involvement with regulatory standards and quality assurance processes.
Engagement in cutting-edge biopharmaceutical manufacturing practices.
Full Job Description
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.
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.
