1st Shift: Mon - Fri 8:00 AM to 5:00 PM, OT as needed

What you will do:

The QC Analyst I will perform routine and complex analytical testing to support lot release, stability, and method development, while accurately documenting results and ensuring all work meets cGMP/cGLP standards.

• Perform routine procedures and complex analytical methods for lot release and stability testing of raw materials, reagents, and products, and prepare technical reports and documentation
• Test and record measurements of various product attributes, including pH, concentration, identity, purity, impurities, and bio-potency.
•  Perform studies to qualify analytical standards, assay controls, and critical reagents.
• Complete documentation to show that tests have been performed according to approved methods and that all results are recorded accurately.
• Maintain laboratory operations in conformance with cGMP/cGLP standards.
• Monitor and record equipment parameters (temperature charts, gas levels, and liquid nitrogen levels).
• Monitor and maintain adequate quantities of laboratory supplies.
• Assist the Quality Control team with technical evaluations of non-conforming test results and events to determine root cause; recommend corrective actions.
• Participate in studies to develop and validate new analytical methods.

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What you need:

Required Qualifications

• Bachelor’s degree in biology, biochemistry, microbiology or chemistry
• Experience with various analytical equipment and methods· 
• Experience with the application of statistics for data analysis
• Experience with computer software (WORD, Excel, etc.)

Preferred Qualifications

• Master’s degree in biology, biochemistry, microbiology, or chemistry
• 1 - 2 years of recent and applicable industry experience, preferably in a pharmaceutical quality control laboratory
• Advanced technical knowledge of analytical methods and function and maintenance of related instruments (including, but not limited to HPLC, UHPLC, UV/Vis spectrophotometers, SDS-PAGE, capillary electrophoresis, brightfield and fluorescence microscopy, cell counters, protein analysis)
• Experience with aseptic technique and mammalian cell cultures
• Experience with inspections, audits, and regulatory agencies/governing bodies.
• Knowledge of GLP/GMP, 21 CFR 211, 21 CFR 820, and ISO13485 standards and regulations     
• Experience maintaining qualified laboratory equipment and creating/reviewing technical documents for an FDA-regulated laboratory

***Highly qualified candidates with alternate, but applicable experience will be considered, including related academic and commercial laboratory research.***

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