QC Analyst Environmental Monitoring

Proclinical is seeking a QC Analyst Environmental Monitoring for a cutting-edge biotech company. This role is on a contract-to-permanent basis on-site in Philadelphia, PA.

The QC Analyst will support quality control environmental monitoring operations. 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.
• 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
• 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 Julia Friedrich at +(1) 617-830-1584 or j.friedrich@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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