Microbiologist II; 1st Shift, Tue-Sat

Position: Microbiologist II (1st Shift, Tue-Sat)
Core Hours

Training hours may vary

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

Essential Duties & Responsibilities

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.

Operate under minimal supervision.

May perform other related duties as required and/or assigned.

Knowledge, Skills & Abilities

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.

Core…