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Job type: Contract

Discipline: Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

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:

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 products

The 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 assigned

Compensation:

$44 hourly

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.

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.

INDCQA

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