Lab Support Analyst, Document Specialist

Proclinical is seeking a Lab Support Analyst, Document Specialist for a cutting-edge biotech company located in Philadelphia, PA.

This role is a Quality Control (QC) Laboratory Support Analyst I who will assist the QC Laboratory Support Manager with the day-to-day upkeep of the QC investigations and supporting documentation. The ideal candidate will have experience working in a GMP-regulated environment. The position will report to the Lab Support Manager, Quality Control.

Must be eligible to work in the US.

Job Responsibilities:

• Issue, maintain, and reconcile quality control forms for environmental monitoring, microbiological, and analytical assay execution.
• Review and approve GMP quality control laboratory testing documentation at the facility with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform final result reporting and COA Generation to support product lot release with adherence to turnaround times.
• Support thorough GMP investigations for out of specification test results and other quality events.
• Support technical problem solving for issues pertaining to GMP quality control.
• Support generation and revisions of documentation, such as SOP, protocols, and reports.
• Perform peer review of laboratory logbooks.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
• Support Health Authority inspections
• Provide input to functional laboratory meetings.
• Due to the nature of testing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change and may involve shift changes.
• Performs other duties as assigned.

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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