Job Title: QC Analyst

Location – Morris Plains, NJ

Shift: Wed–Sat (Rotating) | 7:30 AM – 7:30 PM

Job Summary

Seeking a QC Analyst to support Quality Control testing in a GMP-regulated environment, including microbiology (EM) and bioanalytical testing.

Key Responsibilities

• Perform testing: qPCR, ELISA, Flow Cytometry, cell count/viability.
• Conduct microbiology/EM: sterility, endotoxin, mycoplasma, Gram stain.
• Follow cGMP/GLP guidelines and maintain documentation.
• Support OOS/OOE and deviation investigations.
• Review data, generate reports, and use LIMS (LabWare preferred).
• Assist with method qualification and process improvements.

Qualifications

• Bachelor’s or Master’s in Biology, Microbiology, Biochemistry, or related.
• 2–5 years of QC experience in pharma/biotech/biologics.
• Hands-on GMP lab experience required.

Skills

• Knowledge of cGMP, GLP, and FDA regulations.
• Experience in bioassay and/or microbiology testing.
• Strong documentation, analytical, and communication skills.