Technician I, Microbiology, Quality Control

Role Summary

Technician I, Microbiology, Quality Control — Boca Raton, Florida. Performs environmental monitoring and water sampling within controlled manufacturing areas and QC laboratory.

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.

Qualifications

• Follow the cGMPs 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.
• 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.

Skills

• Compliance with regulatory and quality systems
• Environmental monitoring and sampling techniques
• Laboratory documentation and data integrity
• Equipment calibration and maintenance

Education

• Associate‚Äôs or Bachelor‚Äôs degree in a science discipline.

Experience

• 0-3 years of experience in a laboratory setting.