QC Microbiologist II

AMERICAN REGENT, INC.; Columbus (OH); On-site; USD 45,000 - 65,000; Full time

Job summary

American Regent, Inc. in Columbus, OH is seeking a Microbiology Laboratory professional to perform routine specialized testing including Bacterial Endotoxin testing by Turbid metric and Gel clot, and validate/testing of Raw Material, In-Process, and Antimicrobial Effectiveness Testing samples.

You will assist in drafting event reports, maintain data, and support investigations while ensuring adherence to cGMP, safety, and company policies. Strong communication and teamwork are essential.

Qualifications

• Bachelor’s degree in microbiology, biology, or equivalent Life Science curriculum required.
• Minimum 2–5 years’ experience in a cGMP compliant Microbiology Laboratory.
• Excellent communication skills (oral and written).
• Strong ability to work independently and in a group.
• Organized with strong attention to detail.

Responsibilities

• Perform Bacterial Endotoxin testing by Turbid metric and Gel clot.
• Validate and perform routine testing of Raw Material, In-Process, and Antimicrobial Effectiveness Testing samples.
• Maintain working cultures and perform culture transfer/preparation.
• Test and review organism identifications on Vitek.
• Assist in PQ and Validation of Sterility Testing.
• Assist in investigations/deviation resolution and drafting event reports.

Skills

Communication

Teamwork

Detail-oriented

Education

Bachelor’s degree in microbiology or related Life Science

Tools

Vitek

MS-Office

Job description

Nature and Scope This position in the Microbiology Laboratory will be primarily responsible for all routine specialized testing including Bacterial Endotoxin testing; validation and routine testing of Raw Material, In-Process, and AET samples; and assisting in the drafting of event reports.

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, health and safety requirements. Perform Bacterial Endotoxin testing by Turbid metric and Gel clot for products. Ensure all routine lab work such as reading, log in, water testing is completed. Maintenance of working cultures, culture transfer, and culture preparation. Set up and perform validation and routine testing of Raw Material, In-Process, and Antimicrobial Effectiveness Testing samples. Test and Review completed organism identifications on Vitek. PQ and Validation of Sterility Testing. Assist Microbiologist I with any questions regarding routine testing and training. Begin validation and special studies with the assistance of Microbiology Supervisor. Conducts temperature chart readings daily and changing chart weekly. Maintain and analyze data in database and assist in performance of trend analysis. Assist in the investigation/deviation and drafting of event reports. Working knowledge of BIs for steam, VHP and ETO sterilization. Familiarity with Isolator’s as well as clean rooms. Participate in identified projects. 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. Minimum of 2-5 years’ experience working in a cGMP compliant Microbiology Laboratory (i.e. pharmaceutical industry, food industry, Cosmetics, medical devices, Laboratory Pathology). Strong ability to work both independently and within a group. Good work ethic and highly motivated. Organized individual with strong attention to detail. Excellent communication skills (oral and written). Working knowledge of MS-Office software and PC Skills Required. Ability to work in a fast-paced environment. 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/fml . 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

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]. 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.