Technician I, Microbiology, Quality Control

Technician I, Microbiology, Quality Control

Job Description:

Position Summary

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

Essential Functions (ES) 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.

Compliance Requirements (ES)

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.

Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:

• 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-RailFree shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.