Microbiology QC Specialist

Highly Competitive Salary
  1. Contract
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Philadelphia, USA
Posting date: 14 Aug 2023
QA.MR.56065

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Proclinical is seeking a Microbiology QC Specialist for a cutting-edge biotech company located in Philadelphia, PA.

The quality control environmental monitoring programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, compressed gas monitoring, and/or sterility techniques.

Must be eligible to work in the US.

Job Responsibilities:

  • Perform daily cGMP quality control laboratory microbiological testing activities at our facility.
  • Perform environmental monitoring of the cleanroom areas as scheduled.
  • Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
  • Perform all activities with respect to cGMP compliance.
  • Support thorough cGMP investigations for out-of-specification test results.
  • Support technical problem solving.
  • Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.

Skills and Requirements:

  • Bachelor's degree in a relevant discipline (biological sciences or equivalent).
  • Minimum one (1) year of experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.
  • Successfully interface with multi-disciplined teams.
  • Extremely detail-oriented with strong technical skills.
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
  • High level of ownership and accountability.
  • Demonstrate sense of urgency; ability to recognize time sensitivity.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at +(1) 267-428-7770 or m.raletz@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.

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