FirstBank Jobs

Schedule: Sunday - Wednesday, 6:00 am - 4:30 pm

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. 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. 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. 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 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. Ability to read, understand, and follow work instructions and laboratory test methods. Ability to work independently and cooperatively on a team. Working knowledge of current Good Manufacturing Procedures (CGMP). 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. Understanding of basic math and writing skills to document production activities in batch records and/or log books. 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 Values This position is expected to operate within the framework of Tolmar's Core Values: Consistently operate with the highest standards of ethics and compliance. Take ownership of your actions, success and setbacks. Respect each other and understand that honest collaboration is at the heart of our company success. Go the extra mile to make things happen. Be committed to all we do and the patients we serve. Embrace change with enthusiasm. Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience Bachelor's degree in Microbiology, Biology or closely related field required 1 or more years of laboratory experience including Microbiology within a regulated industry.

Additional Requirements Valid driver's license and acceptable motor vehicle record required. May require overtime and occasional holiday work (overtime pay on non-salary paid positions).

Working Conditions Working conditions may include standing for long periods of time in various manufacturing and laboratory areas, and desk work. Laboratory setting; will be exposed to bio-hazardous materials, hazardous waste, and pharmaceuticals.

Compensation and Benefits Annual pay range $55,000 - $60,000 Benefits information: https://www.tolmar.com/careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and... for full information follow application