Microbiologist II; 1st Shift, Tue-Sat

• Training hours may vary

To ensure product quality as it relates to raw material, components, product and environmental microbial testing.

• Perform job in a laboratory and clean room environment requiring clean room gowning, including but not limited to:
• Company-provided Scrubs
• Shoe Covers and Sterile Boot Covers
• Hairnets (and beard covers as applicable)
• Tyvek Coveralls
• Gloves
• Full-face masks/hoods
• Goggles
• Chemical Protection PPE
• Assist in performing environmental monitoring in the general and aseptic manufacturing environment.
• Assist in performing aseptic gowning qualifications and participate in aseptic process simulations.
• Perform routine quality control product testing on pharmaceutical items under GMP and ISO conditions, including sterility testing in an isolator
• Perform utilities sampling and testing (compressed gas, steam, and water).
• Assist with the setup of the laboratory and management of daily lab operations (prepare media and solutions).
• Incubate and enumerate organisms on cultured media.
• Maintain stock cultures of bacteria and fungi.
• Maintain notebooks according to GMP guidelines. Preparation of reports and summaries
• Write and execute test methods and work instructions
• Execute test method transfers and instrument validations.
• Provide EM data support including entry, review and tracking of EM data.
• Assist with utility and facility qualifications.
• Assist with investigations (Excursions, CAPA) to aid in the determination of root causes for environmental excursions and lab deviations within and outside of the lab.
• Assist with trend reporting and data analysis.
• Assist with training other members of the microbiology department and aseptic operations on MODA and viable sampling processes and techniques.
• May perform other related duties as required and/or assigned.

• Understanding of CGMP’s and GDP’s
• Experience with routine culture/molecular techniques, microbial identification procedures, endotoxin and bacterial plating instruments preferred.
• Some knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Strong verbal, written communication skills and computer skills are required.
• Provide necessary coaching, guidance, and mentorship to specialists and associates related to improvements of job performance.
• Interact with peers and members of other departments in team settings in a professional manner.
• Must be goal-oriented, quality-conscientious, and customer-focused.
• Knowledge of laboratory science principles, microbiology lab equipment and microbiology concepts.
• Ability to read, understand, and follow work instructions and laboratory test methods.
• Ability to work independently and cooperatively on a team.
• Effective troubleshooting and problem-solving skills
• Ability to stand for extended periods of time (up to 8 hours or more).
• Understanding of basic computer software.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Ability to follow and understand written production records and validation protocols.
• Ability to work within multi-functional project teams and independently with minimum supervision.
• Ability to manage multiple projects simultaneously.
• Understanding basic math and writing skills to document production activities in batch records and/or logbooks.
• Must be able to keep accurate records and able to perform mathematical calculations.
• Ability to legibly complete required documentation.
• Strong attention to detail required for documentation in production documents.
• Capability to operate on a fast-paced manual process using environmental monitoring equipment.
• Maintain and train others on Aseptic technique and work in an aseptic environment.

• This position is expected…