QC Microbiologist II

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/fmlaen.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

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