Technician I, Microbiology, Quality Control

Position Summary

The Technician I, Microbiology, Quality Control performs environmental monitoring and water sampling within controlled manufacturing areas and QC laboratory.

Essential Functions and Responsibilities

• Perform environmental sampling within the controlled manufacturing areas in accordance with approved Standard Operating Procedures (SOPs) (e.g. viable air, total airborne, and surface test methods).
• Perform water, compressed gas, and utility system sampling according to established SOPs.
• Ensure calibration and maintenance of monitoring/test equipment are current.
• Record, label and transport samples accurately to the laboratory for analysis.
• Document results in logbooks, worksheets and electronic systems in compliance with Good Documentation Practices (GDP).
• Identify, report and participate in the generation of alert and action-level excursion documentation, as needed.
• Maintain awareness of safety, contamination control, and environmental conditions within the manufacturing facility.
• Participate in data trending, reporting and continuous improvement initiatives.
• Support audit and inspection readiness initiatives.
• Perform other duties, as directed by the supervisor/management, to support company directives and initiatives.
• Ability to work flexible shifts, weekends, or holidays as required.

Competencies

• Ability to follow the cGMP’s and procedures with great attention to detail
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
• Possess time management skills and be able to balance multiple job assignments at once

Experience Requirements

• Familiarity with microbiological testing is desired.
• Self-motivated and able to work autonomously while responsible for multiple priorities.
• Strong attention to detail and commitment to data integrity.
• Ability to follow SOPs and work in a regulated environment.
• Effective communication and teamwork skills.
• Ability to gown into controlled manufacturing areas multiple times per day.
• Function in areas subject to exposure to infectious material (human-source products), toxic chemicals, chemical fumes/odors, electrical hazards, and temperature extremes within coolers/freezers.
• Ability to work flexible shifts, weekends, or holidays as required.

Education Requirements

Associate’s or Bachelor’s degree in a science discipline.

Experience Requirements

0-3 years of experience in a laboratory setting.

Preferred Experience

Experience working in a regulated environment (FDA, EPA, etc.) is preferred.