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Molecular Biologist
2 months ago
We are seeking a highly skilled Molecular Biologist to join our team as a Quality Control Specialist in Cell Based Immunology. The successful candidate will be responsible for performing daily GMP Quality Control laboratory testing activities with minimal to no errors, ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
Key Responsibilities- Quality Control Laboratory Testing: Perform daily GMP Quality Control laboratory testing activities at the facility with minimal to no errors, ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
- Data Analysis and Reporting: Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
- GMP Compliance: Perform all activities with respect to GMP/GDP compliance.
- Investigations and Problem Solving: Support thorough GMP investigations for out of specification test results and other quality events, and support technical problem solving for issues pertaining to GMP Quality Control.
- Product Stability Programs: Support product stability programs including execution of stability testing, stability data analysis and trending, and final reporting of stability data.
- Documentation and Review: Assist in the generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls, and perform peer review of laboratory data and logbooks.
- Efficiency and Productivity: Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Health Authority Inspections: Support Health Authority inspections.
- Team Collaboration: Provide input to functional laboratory team meetings.
- Additional Responsibilities: Other responsibilities as assigned.
- Education: Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Experience: Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control role.
- Technical Skills: Experience with two or more of the following: Flow Cytometry, Cell based ELISA, NC200.
- Interpersonal Skills: Successfully interface with multi-disciplined teams.
- Attention to Detail: Extremely detail-oriented with strong technical skills.
- Time Management: Ability to effectively manage multiple priorities involving aggressive, changing timelines at a high level of productivity.
- Ownership and Accountability: High level of ownership and accountability.
- Urgency and Prioritization: Demonstrate sense of urgency; ability to recognize time sensitivity.
- Technical Proficiency: Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
- Cell Therapy Experience: Experience with cell therapy products.
- Shift Schedule: Shift Sunday through Thursday.