QC Environmental Monitoring Technician I (7:30am-4pm)

AMERICAN REGENT, INC.; Shirley (NY); On-site; USD 33,000 - 34,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

Matching 401k

Wide range of other benefits

Job summary

American Regent, Inc. seeks an Environmental Monitoring professional to support sterile manufacturing by performing environmental sampling (air, surfaces, water) and personnel monitoring in a classifiable facility.

You will document results in LabWare LIMS and ensure compliance with SOPs and cGMPs. The role requires gowning qualifications, meticulous record-keeping, and the ability to work in a fast-paced environment with manufacturing teams.

Qualifications

• High school diploma or GED required.
• Associate degree in microbiology or related field preferred.
• 1 year lab or manufacturing experience in microbiology preferred.
• Knowledge of aseptic technique preferred.
• Must maintain gown qualifications for EM support.
• Strong documentation and math skills.
• Good communication and ability to work independently or in a team.

Responsibilities

• Perform environmental monitoring sampling (air, surfaces, water, personnel) in aseptic areas.
• Record results and report deviations per specifications.
• Enter data into LabWare LIMS and assist with data retrieval and trending.
• Ensure work complies with SOPs, cGMPs, health and safety requirements.
• Maintain accurate records and adhere to Good Documentation Practices.

Skills

Communication skills

Teamwork

Attention to detail

MS-Office proficiency

Education

High School Diploma or GED

Associate degree in microbiology or related field (preferred)

Tools

LabWare LIMS

Job description

Nature and Scope

The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility.

Essential Duties and Responsibilities

• Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
• Manage assigned daily workload to meet requirements and perform sampling as per the schedule.
• Must complete and maintain gowning qualifications for support areas as well as the Aseptic Processing Area to work in clean rooms.
• Perform environmental monitoring activities including sampling of air (Viable and Non-viable), compressed air and nitrogen, surface, and personnel inside the classified manufacturing areas.
• Conduct water sampling throughout facility.
• Complete incubation, transfer and final reading of samples if needed.
• Record results and report deviations as per specifications.
• Capture sampling life cycles in the LIMS software and assist with data entry for retrieval and trending from Labware LIMS.
• Maintain accurate records of work performed in Labware LIMS and Laboratory documentation systems according to Good Documentation Practices, Standard Operating Procedures (SOPs) and policies.
• Maintains compliance with all required SOPs and policies.
• Communicate any discrepancies or deviations to supervision/management upon discovery.
• Author or help data collection for assigned investigation report related to EM/PM events.
• Perform clean room behavior and area assessments as per procedures if needed.
• Review environmental and personnel monitoring sample results in Labware LIMS if needed.
• Input data/results into database and conduct trend analysis.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• High School Diploma or GED equivalent required.
• Associate degree in microbiology, biology or related scientific field preferred.
• One year experience in academic or industry work experience in laboratory setting or manufacturing with focus on microbiology preferred.
• Knowledge of aseptic technique preferred.
• Must be able to maintain APA gown qualification for EM support.
• Ability to perform basic mathematical calculations.
• Ability to work independently and as a team with minimal supervision.
• Organization and attention to detail.
• Excellent communication skills (Oral and Written).
• Working knowledge of MS-Office software and PC Skills Required.
• Good work ethic and highly motivated.
• Good time-management skills.
• Ability to work in a fast-paced environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime, weekend and holidays as needed.

Physical Environment and Requirements

Physically able to wear and aseptically don cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.

PPE is essential for the health and safety of employees. Employees must maintain a clean‑shaven appearance each working shift to wear tight‑fitting respirators properly.

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employee must be able to occasionally lift and/or move up to 25 pounds. Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.

Expected hourly range: $23.61 - $25.00

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

Benefits

• healthcare
• life insurance
• profit sharing
• paid time off
• matching 401k
• wide range of other benefits

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlb.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.

American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.