QC Environmental Monitoring Technician I - 2nd Shift (1:30 PM to 10:00 PM)

American Regent; Hilliard (OH); On-site; USD 42,000 - 52,000; Full time

Job summary

American Regent is seeking an Environmental Monitoring Team I to perform environmental monitoring in our sterile manufacturing facility. Responsibilities include air, water, surface and personnel sampling, data entry, trend analysis, and reporting deviations in accordance with cGMPs.

The role requires a High School Diploma or GED, with preferred associates in microbiology or related field; strong attention to detail, ability to work overtime, and good communication skills are essential for

Qualifications

• High School Diploma or GED required.
• Associate degree in microbiology, biology or related field preferred.
• Experience in a lab or manufacturing setting with a focus on microbiology preferred.
• Knowledge of aseptic technique preferred.
• Must be able to read documents in English such as SOPs and manuals.

Responsibilities

• Plan daily workload to meet requirements.
• Conduct environmental monitoring activities inside sterile manufacturing areas.
• Conduct air, surface and water sampling and personnel monitoring.
• Record results and report deviations from specifications.
• Input data into the database and conduct trend analysis.
• Communicate discrepancies or deviations to supervision/management.

Skills

Attention to detail

Communication skills

Independent worker

Team player

Reading SOPs

Education

High School Diploma or GED

Associate degree in microbiology or biology

Tools

MS Office

Job description

Nature and ScopeThe 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 and assists the manufacturing department, and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT I position is primarily responsible for performing environmental monitoring activities including water collection, air, surface and personnel monitoring within the sterile manufacturing facility.Essential Duties and ResponsibilitiesNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.Plan daily workload to meet requirements.Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas.Conduct water sampling throughout facility.Record results and report deviation from specifications.Communicate any discrepancies or deviations to supervision/management upon discovery.Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.Inputs data into database and conduct trend analysis.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.High School Diploma or GED equivalent required. Associate Degree in microbiology, biology or related scientific field preferred.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 Class 100 Certification for EM support.Ability to work independently 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.Ability to work in a fast paced environment.Ability to work in a team oriented environment.Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.Ability to work overtime as needed.Physical Environment and RequirementsPhysically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.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.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/fmlaen.pdfKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdfAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.· Our recruiting process includes multiple in person and/or video interviews and assessments.· If you are unsure about the legitimacy of a message, contact John Rossini at [e-mail] before responding.· We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].