Quality Control Analyst, Deviations

Proclinical is seeking a Quality Control Analyst, Deviations for a cutting-edge biotech company located in Philadelphia, PA.

The QC Analyst will assist the Laboratory Manager with the day-to-day upkeep of the QC laboratories including but not limited to collecting data for trending, maintaining positive control inventories for various QC assays, and uploading assay records to the document management system.

Must be eligible to work in the US.

Job Responsibilities:

• Assists Lab Support Manager and lead investigators with responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
• Performs cross-functional investigations in support of deviations and laboratory investigations.
• Gathers data in support of deviations and maintain a trending database of applicable metrics.
• Revise Quality documents in support of deviation mitigation and/or CAPAs.
• Other responsibilities as determined.

Skills and Requirements:

• Bachelor's degree in a relevant discipline (biological sciences or equivalent)
• 0-2 years of experience in the biopharmaceutical industry within a cGMP Quality Control role; experience with cell and/or gene therapy products is a plus
• Basic knowledge of biological drug development with respect to Quality Control
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges

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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