QC Analyst, Lab Support

Proclinical is seeking a QC Analyst, Lab Support for a leading biotech company located in Philadelphia, PA. This position will support the laboratory manager with daily upkeep of QC laboratories including collecting data for trending, maintaining positive control inventories for various QC assays as well as uploading records to the document management system.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• Upload and create records of reviewed QC assay records to the Document Management System
• Assists Lab Support Manager and lead investigators with responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA)
• Assists in maintaining a Critical Reagent Inventory for the QC Qualification and Testing Program
• Assists in maintaining a Positive Control Inventory for the QC Qualification and Testing Program
• Gathers data and assists in maintaining a Trending Program for key attributes of the various company programs
• Perform laboratory testing to investigate and/or trouble-shoot atypical/out of specification results
• Holiday and weekend work may be occasionally required
• Other responsibilities as assigned

Skills and Requirements:

• Bachelor's degree in a relevant discipline (biological sciences or equivalent)
• At least 1 year of experience in the biopharmaceutical industry within a cGMP Quality Control role
• Experience with cell and/or gene therapy products is a plus
• Experience with cell-based assays, ELISA and/or flow cytometry 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
• In-depth knowledge of GDPs
• 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 Miranda Gilmer at (+1) 570-277-7065 or m.gilmer@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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