Quality Control /Environmental Monitoring Technician

Role Summary

Quality Control / Environmental Monitoring Technician

Environmental Monitoring / QC Technician Microbiology will report to the QC Supervisor, Microbiology or equivalent. This position will conduct routine and non-routine environmental monitoring of the manufacturing facilities and associated utilities, as well as microbiology analysis.

Responsibilities

• Conducts Environmental Monitoring: Performs routine and non-routine sampling of manufacturing environments (air and surfaces) and utilities (WFI, USP Water, Pure Steam, Clean Compressed Air). Maintains gowning qualifications for sterile environments.
• Ensures cGMP Compliance: Upholds cGMP, safety, and environmental standards within the QC lab, generating accurate and compliant data. Participates in internal assessments and audits.
• Performs Microbiological Testing: Executes routine and non-routine analyses of raw materials, in-process materials, finished goods, and stability samples. Conducts a variety of microbiology tests, including bioburden, sterility, and microbial identifications.
• Supports Investigations and Deviations: Assists in the investigation of out-of-specification/out-of-trend results, environmental monitoring excursions, and deviations. Contributes to the preparation of Certificates of Analysis.
• Develops and Maintains QC Methods: Assists in developing, qualifying/validating, and transferring new test methods. Contributes to the writing and revision of testing methods, specifications, SOPs, and validation protocols/reports. Maintains lab inventory and performs routine equipment maintenance and cleaning.

Qualifications

• Education: High School Diploma/GED with 5 years experience, BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field, or comparable experience.
• Experience: Technical skills in Environmental Monitoring to include, but not limited to, monitoring of manufacturing environment and utilities.
• Excellent computer, documentation, communication, and organizational skills required.

Skills

• Experience in cGMP environment (preferred)
• Experience with environmental monitoring, water testing, sterility, and mycoplasma (preferred)
• Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities
• Experience related to method development/validation
• Strong attention to detail, strong problem-solving skills, and ability to work in a cross-functional team environment

Education

• As listed in Qualifications

Additional Requirements

• none