QC Microbiologist I

American Regent, Inc.; Columbus (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent Inc. seeks a Microbiology Laboratory Specialist to perform and coordinate microbiological testing on in-process and finished products, and to monitor manufacturing facilities and utility systems for compliance.

The role requires planning daily workloads, executing tests (Gram stain, microbial ID, LAL, environmental monitoring), and maintaining meticulous records in a cGMP environment. Ideal candidates will have a Bachelor's in Microbiology or related Life Sciences, 1 year of

Qualifications

• Bachelor's degree in Microbiology, Biology, or life sciences.
• 1 year experience in pharmaceutical or related industry preferred.
• Ability to work independently and as a team.
• Familiarity with aseptic technique and clean room procedures.
• Excellent written and oral communication; MS-Office skills.

Responsibilities

• Plan daily workload to meet requirements.
• Conduct microbiological testing including Gram stain, microbial identification, LAL, environmental monitoring, growth promotion, microbial limits and water testing.
• Conduct environmental monitoring in sterile manufacturing areas (air, surfaces, personnel).
• Perform water sampling throughout the facility.
• Document findings and report discrepancies per standards and cGMP.
• Calibrate and verify performance of small laboratory instruments.
• Perform media and glassware preparation; operate autoclaves.
• Maintain and analyze data; conduct trend analysis.
• Participate in projects and perform other duties as assigned by management.

Skills

MS-Office

Communication skills

Teamwork

Attention to detail

Aseptic technique

Education

Bachelor's degree in Microbiology, Biology, or life sciences

Job description

Nature and Scope

This position in the Microbiology Laboratory will be primarily responsible for performing, coordinating and tracking the microbiological testing for in-process and finished products as well as monitoring of controlled manufacturing facilities and utility systems.

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.

• Plan daily workload to meet requirements.
• Conduct microbiological testing including Gram stain, microbial identification, LAL, environmental monitoring, growth promotion, microbial limits and water testing.
• Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas.
• Conducts all water samplings throughout manufacturing facility.
• Logging, reading and recording samples and data per cGMP and applicable compliance requirements.
• Calibration, performance verification of small laboratory instruments.
• Perform media preparation, glassware preparation and operate autoclaves.
• Documents findings and report discrepancies from standards.
• Communicate any discrepancies or deviations to management upon discovery.
• Conducts chart readings daily and changing chart weekly.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements.
• Maintain and analyzes data in database and conduct trend analysis.
• Participate in projects identified
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To 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.

• Bachelor's degree in Microbiology, Biology, or equivalent Life Science curriculum required.
• One year experience in the pharmaceutical industry, food industry, Cosmetics, medical devices, Laboratory Pathology preferred.
• Strong ability to work independently and as a team.
• Ability to learn clean room technology and use of aseptic technique.
• Organized individual with strong 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 overtime as needed.

Physical Environment and Requirements

• Physically able to wear laboratory 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.

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/fmlink.pdf
• Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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].