Job Description

Job Description

Job Description

Salary: $20/hr DOE

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 bachelors 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.

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