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.

Education / Experience / Core Competencies & Behavior Requirements

• Education Requirements: Associate’s or Bachelor’s degree in a science discipline.
• Experience Requirements: 0-3 years of experience in a laboratory setting.
• Core Competencies & Behaviors:
  • 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.
  • Able to follow SOPs and work in a regulated environment.
  • Effective communication and teamwork skills.
  • Able 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.
  • Able to work flexible shifts, weekends, or holidays as required.

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.

Preferred Experience

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

Compliance Requirements

• The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities.
• This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations.
• Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station

ADMA Biologics

ADMA Biologics is an Equal Opportunity Employer.