Quality Control Analyst I, II, or Sr.

• Shift options: Sunday - Thursday or Tuesday - Saturday
• Work hours: Approximately 8:00 AM – 5:00 PM, with potential for overtime, weekends, and holidays to meet turnaround times
• Location: Fully onsite in Philadelphia, PA

Pay Rate:

• Level I: $38/hr. (firm) - 2+ years of experience required
• Level II: $45/hr. - 3-4+ years of experience required
• Senior Level: Competitive Bid - 5+ years of experience required
• Location: Philadelphia, PA (close proximity to Camden and Cherry Hill, NJ)
• Contract Length: Initial 6 months, with potential for FTE conversion based on performance
• No relocation assistance available.
• Education: Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, or a related scientific field (or equivalent combination of education and experience).
• Experience: Minimum 2-5 years of GMP experience in a pharmaceutical industry Quality Control role.

Overview:

We are seeking Quality Control Analysts for a new cell therapy facility located in Philadelphia, PA. Multiple positions are available across three levels (Level I, II, and Senior), all requiring hands-on laboratory experience and a focus on cell therapy products. The successful candidates will support GMP-compliant QC testing for cell-based therapies, ensuring accurate, timely results for drug product release and stability testing.

Key Responsibilities:

• Conduct GMP Quality Control testing for cell therapy products, ensuring compliance with applicable procedures, standards, and GMP regulations.
• Analyze data and report final results to support product lot release, adhering to turnaround times.
• Act as a subject matter expert (SME) for specific assays, providing training to new lab personnel.
• Assist in GMP investigations related to out-of-specification results and other quality events.
• Support technical problem-solving efforts related to GMP Quality Control activities.
• Execute stability testing and report stability data as part of product stability programs.
• Contribute to the development and revision of documentation such as SOPs, protocols, and reports.
• Participate in the initiation and support of quality records (deviations, laboratory investigations, CAPAs, and change controls).
• Perform peer reviews of laboratory data and logbooks to ensure accuracy and compliance.
• Maintain high standards of efficiency and produce accurate, high-quality results.
• Support Health Authority inspections and provide input to functional laboratory team meetings.

Required Qualifications:

Hands-on experience with at least one of the following:

• Multicolor Flow Cytometry
• Cell-based ELISA
• Cell culture and cell enumeration (e.g., NC-200)
• Experience with technical writing, including test methods, SOPs, and protocols.
• Detail-oriented with strong technical skills and a high level of accountability.
• Proficient in Microsoft Office Suite (Outlook, Excel, Word, PowerPoint).
• Ability to work under pressure, demonstrate urgency, and meet deadlines.