Quality Control Analyst II - Microbiology

🔬 We're Hiring : Quality Control Analyst II - Microbiology! 🔬

We are seeking a detail-oriented Quality Control Analyst II specializing in Microbiology to ensure product safety and compliance. The ideal candidate will have expertise in microbiological testing, laboratory procedures, and quality assurance protocols to maintain the highest standards in our manufacturing processes.

📍 Location : Philadelphia, Pennsylvania

🗓️ Schedule : Sunday to Wednesday | Night (7 PM - 6 AM) or Day (7 AM - 6 PM)

What You'll Do :

🧪 Perform daily GMP Quality Control laboratory testing activities at the iCTC facility

📋 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.

📊 Support product stability programs, including execution of stability testing, stability data analysis and trending, and final reporting of stability data.

📝 Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls

👁️‍🗨️ Act as subject matter expert (SME) on one or more assays and train new laboratory personnel.

⚖️ Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

What We're Looking For :

✅ Bachelor’s degree in a relevant discipline (biological sciences or equivalent)

✅ 3 - 8 years of experience in the pharmaceutical industry within a Quality Control role.

✅ Previous experience with Good Documentation Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP).

✅ Extremely detail-oriented with strong technical skills

✅ High level of ownership and accountability

✅ Demonstrate sense of urgency; ability to recognize time sensitivity

Preferred Qualifications :

➕  Advanced degree (MSc. preferred)

➕  Experience with cell therapy products is a plus.

Ready to make an impact? 🚀 Apply now and join our team!