Job Description

Position Summary: Performs various microbiological sampling and testing in an FDA regulated environment, including personnel and environmental monitoring. Essential Functions: Perform and review environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, personnel, and non-viable particulate) as well as inspection for compliance. Perform and support Media Fill Validations, Engineering Validations and Cleaning Validations. Accurate/legible completion of records and documents for tests performed, and accurate computer data entry/trending/presentation. Raw Material/Prefiltration Bioburden/Water sample/Filter integrity testing. Media check in and growth promotion. Equipment preparation and autoclaving. Preparation of microbial ID samples. Off testing of incubated environmental monitoring media, testing samples, and Media Fills. Use standard laboratory equipment including but not limited to balance, incubator, autoclave, pipettes, and water bath. In-process/finished product sample inspection and submission to in-house/third party laboratories. Stocking/ordering lab supplies. Assist with revision of microbiology/laboratory procedures and documentation. Maintenance of close communication and interaction with QC/QA/Production management. Utilization of programs for daily workflow (e.g. LIMs). Utilization of a Quality Management System (QMS) for training and document review/ improvements. Potential involvement in procedural/policy improvements within the department. Support microbiology laboratory investigations including NONC/EE/Issue reviews/OOS/OOT/No Tests/CAPA. Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner. Responsible for cleaning and upkeep of the laboratory and testing areas. Support gown assessments as needed. May perform other duties as qualified/assigned, including but not limited to Sterility, Endotoxin, MET testing, NONC issuance. Any additional activities as dictated by updates to Standard Operating Procedure and Policies to ensure compliance with cGMP and regulatory bodies. Education and Experience: A bachelor's degree (science related field preferred) or associates degree is preferred. In lieu of a degree, a high school diploma or equivalent and a minimum of 2 year experience in a regulated environment or Pharmaceuticals may be considered. Knowledge, Skills and Abilities: Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown upon completion. Accurate/legible completion of records and documents for tests performed, and accurate computer data entry. Good time management skills, attention to detail, ability to adhere to implemented standard operating procedures/policies, ability to communicate professionally with contract laboratories regarding sample testing, communication with others, and flexibility for new opportunities/tasks. Works well independently and in a team orientated environment. Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology. Experience with standard laboratory equipment including balance, incubator, autoclave, pipettes, or water bath is preferred. Knowledge of ISO, USP or GMPs standards is a plus. Knowledge of computer skills (e.g. Windows, Word, Excel, Power Point) Physical Requirements / Working Conditions: Must have a reliable method of transportation for work travel. Ability to wear high level full body aseptic gowning with face mask for long periods of time is required. Ability to stand for long periods of time. #J-18808-Ljbffr

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