Job Description
Job DescriptionSalary: $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.