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Company

Proclinical Staffing

Address Philadelphia, PA, United States
Employment type CONTRACTOR
Salary
Category Medical Equipment Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-05-23
Posted at 1 year ago
Job Description
Proclinical is seeking a QC Analyst for a start-up biopharmaceutical company located in Philadelphia, PA. This position will support the ramp up of QC and other activities in a newly built facility for cell therapy products.
Must be eligible to work in the US.
Job Responsibilities
  • Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls
  • Other responsibilities as assigned
  • Perform peer review of laboratory data and logbooks
  • Support thorough GMP investigations for out of specification test results and other quality events
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results
  • Support product stability programs including execution of stability testing, stability data analysis and trending, and final reporting of stability data
  • Support Health Authority inspections
  • Provide input to functional laboratory team meetings
  • Perform data analysis and final result reporting to support product lot release with adherence to turnaround times.
  • Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations
  • Support technical problem solving for issues pertaining to GMP Quality Control
Skills And Requirements
  • Extremely detail-oriented with strong technical skills.
  • Successfully interface with multi-disciplined teams
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
  • Bachelor's degree in a relevant discipline (biological sciences or equivalent).
  • Demonstrate sense of urgency; ability to recognize time sensitivity
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
  • Experience with one or more of the following: Flow Cytometry, Cell based ELISA, NC200
  • High level of ownership and accountability
If you are having difficulty in applying or if you have any questions, please contact Kelly Campbell at (+1) 570-277-7115 or [email protected].
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