Quality Control Analyst
Tech Observer, Morris Plains, NJ, United States
Job Summary
Shift: Wed–Sat (Rotating) | 7:30 AM – 7:30 PM
Seeking a QC Analyst to support Quality Control testing in a GMP-regulated environment, including microbiology (EM) and bioanalytical testing.
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.
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Shift: Wed–Sat (Rotating) | 7:30 AM – 7:30 PM
Seeking a QC Analyst to support Quality Control testing in a GMP-regulated environment, including microbiology (EM) and bioanalytical testing.
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.
#J-18808-Ljbffr