Scientist II, Quality Control - Microbiology

The Role

• Perform microbiological testing of raw materials, in-process materials, finished products, stability, and validation samples according to approved methods, procedures, protocols, specifications, and compendial requirements.
• Conduct preparatory testing, method suitability, and nonsterile product testing in accordance with USP , USP , and USP , including sample preparation, dilution, neutralization, recovery, and testing conditions.
• Perform microbiological testing of purified/potable water, compressed gases, manufacturing areas, utilities, and environmental samples; conduct environmental monitoring and statistical trending of EM data.
• Cultivate, recover, isolate, and perform preliminary characterization of bacteria, yeast, and mold, including Gram staining and colony morphology; maintain stock/reference cultures and challenge organisms.
• Prepare microbiological media, reagents, diluents, neutralizers, and test organisms; support growth promotion testing, method transfers, suitability, verification, qualification, and validation activities.
• Interpret, document, and report microbiological results in LIMS and other electronic laboratory systems; perform technical review/auditing of calculations, test records, data, and reports for accuracy, cGMP compliance, and data integrity.
• Initiate, conduct, and write laboratory investigations for microbiological excursions, atypical results, deviations, invalid tests, and environmental monitoring events; evaluate root cause and support corrective/preventive actions.
• Write and revise SOPs, methods, protocols, investigations, and technical reports; support equipment qualification, training, audits/inspections, laboratory safety, inventory, and special projects while working independently with minimal supervision.
• Other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor of Arts or Bachelor of Science with college coursework in Microbiology, Biology, Biological Sciences, or a related life-science discipline.
• At least eight years of experience in a microbiology, pharmaceutical, biotechnology, dietary supplement, or other regulated laboratory environment.
• Extensive hands-on experience with microbiological testing of raw materials and finished products, including preparatory testing, method suitability, recovery assessments, microbial enumeration, and specified microorganism testing in a cGMP laboratory.
• Strong working knowledge and hands-on experience with USP , USP , and USP ; experience testing nonsterile pharmaceutical products is strongly preferred.
• Experience with environmental monitoring, including viable air and surface monitoring, and demonstrated ability to statistically trend EM data using approved software and communicate meaningful trends and emerging adverse conditions.
• Experience with microbiological testing of pharmaceutical water systems and manufacturing utilities; aseptic microbiological laboratory techniques; preparation and handling of media, reagents, diluents, neutralizers, and test organisms; growth promotion testing; reference culture handling; and autoclave/sterilization practices.
• Knowledge of bacterial, yeast, and mold recovery, isolation, and preliminary characterization, plus experience coordinating isolate identification through qualified contract laboratories, including handling, documentation, shipment, and review of identification results.
• Extensive experience conducting and writing microbiological laboratory investigations, including excursions, deviations, atypical results, and invalid tests; ability to evaluate root cause and support appropriate corrective and preventive actions.
• Strong technical writing skills and demonstrated experience writing or revising SOPs, microbiological test methods, protocols, investigations, and technical reports.
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Ability to work extended hours or off-hours as required.

Preferred Skills & Background

Writing laboratory investigations and USP preparatory testing/qualification for chapters and strongly preferred.