- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control role
- Experience with two or more of the following: Flow Cytometry, Cell based ELISA, NC200
- Successfully interface with multi-disciplined teams
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive, changing timelines at a high level of productivity
- High level of ownership and accountability
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
- Experience with cell therapy productsThe Quality Control Analyst: Cell Therapy will:
- Perform daily GMP Quality Control laboratory testing activities with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations
- Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
- Perform all activities with respect to GMP/GDP compliance
- Support thorough GMP investigations for out of specification test results and other quality events
- Support technical problem solving for issues pertaining to GMP Quality Control
- Support product stability programs including execution of stability testing, stability data analysis and trending, and final reporting of stability data
- Assist in the generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls
- Perform peer review of laboratory data and logbooks
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results
- Support Health Authority inspections
- Provide input to functional laboratory team meetings
- Other responsibilities as assignedCompensation:
$44 hourly
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) or
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Quality Control Analyst: Cell Therapy - Philadelphia, United States - Proclinical
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Description
Quality Control Analyst: Cell Therapy - Contract - Onsite
Proclinical Staffing is seeking a Quality Control Analyst: Cell Therapy to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.
Skills & Requirements: