Lab Technician

Job Summary

A Lab Technician I in Quality Control Microbiology is responsible for intermediate level expertise of microbiological test methods and instrumentation. The QC Microbiology department contains five main functional groups, each with slightly varying activities. The technician collaborates with senior personnel and mentors less experienced analysts.

• Ensure compliance with company documents, programs, and Health, Safety, Environment, Energy, and Quality Management Systems.
• Understand department priorities and plan ahead.
• Perform peer review of data for accuracy, completeness and conformance to specifications.
• Inform supervisory personnel of all relevant events impacting operations and performance, including discrepancies and out‑of‑limit conditions.
• Articulate work‑related issues clearly to management and peers.
• Maintain knowledge of cGMPs, GLPs, and current compendial methods.
• Teach or coordinate teaching of training modules and laboratory techniques to new analysts.
• Assist in authoring investigative studies (OOS, OOT, OOL, invalid tests) and related documents.
• Support senior personnel in investigations, special testing, and project work.
• Investigate deviations from SOPs for potential impact to product and materials; derive root cause.
• Update SOPs or methods of analysis to keep them current.
• Ensure safety policies are adhered to and recommend improvements.
• Maintain equipment, calibrations not handled by metrology or maintenance.
• Perform other duties as assigned.
• Maintain current training compliance through the company’s Learning Management System (LMS).

• Schedule, initiate, coordinate, and perform routine and non‑routine environmental monitoring per established procedures.
• Assess environmental conditions using various sampling methods (water systems, compressed gas, personnel).
• Identify out‑of‑limit results and initiate OOL investigations.
• Achieve ISO Class 5 gowning certification.
• Process paperwork, LIMS input, and approvals for release by QA Critical Systems.
• Record OOL events and change controls in eQMS.
• Assist in investigation of environmental OOL excursions.
• Coordinate responses and actions to environmental issues.
• Maintain laboratory housekeeping and inventory of media and reagents.
• Perform microbial identification activities for samples, including sub‑culture, Gram staining, etc.

• Schedule, initiate, coordinate, and perform routine testing of in‑process, finished products, raw materials, and components.
• Conduct environmental monitoring during bioburden and sterility testing.
• Assist in microbial identification activities.
• Maintain testing equipment and coordinate requalification, preventive maintenance, and calibration.
• Process paperwork, LIMS input, approvals for release by QA.
• Provide data for annual product reviews, investigational requests, and validation studies.

• Validate microbiological test methods for new products (APIs, in‑process, finished products).
• Perform studies to support new products, method justifications, and standard validations.
• Conduct routine testing on validation batches.
• Review and approve testing results; revise SOPs as necessary.
• Execute study protocols for production and lab method validation.
• Support plant and lab equipment requalification studies.
• Assist in tech transfer process validation protocols.
• Perform microbiological testing for process validation studies.

• Develop and execute BFR study protocols to validate sterilizing‑grade filters.
• Perform routine testing for validation activities (viability, spike‑flush, filter compatibility).
• Prepare microbial suspensions, media, reagents.
• Monitor laboratory environmental conditions.
• Review and approve peer work results.
• Assist in lab qualification and requalification studies.
• Update SOPs related to BFR in Documentum.
• Investigate nonconforming results, identify root causes, and support CAPAs.
• Maintain equipment; coordinate preventive maintenance, calibration, requalification.

• Complete all microbial identification activities using the MALDI-m.
• Maintain accurate records of identifications.
• Report…