Job Summary: The Microbiologist will manage samples sent to a 3rd party lab for testing, perform in house environmental monitoring of controlled spaces, investigate Out of Specification results, trend data, perform audits and design remediation plans for any environmental monitoring issues. Follow procedures, policies, and requirements of the Quality Control department. Documents all work according to SOP’s. Follows Safety, Health, and Environmental policies and procedures.
Job Activities and Responsibilities:
- Analyzes environmental monitoring and microbiological trends and evaluate microbial growth identification.
- Performs surface and air sampling according to SOP’s.
- Performs in house endotoxin testing.
- Conducts performance and compounding process investigations related to sterility assurance and aseptic controls.
- Prepares and presents technical microbiology and sterility assurance investigative and trend reports to management.
- Formulates microbiology or sterility assurance recommendations for disposition or other actions related to process deviation or product complaints investigations.
- Schedules routine analysis of finished product, raw material or environmental samples according to established specifications and procedures.
- Performs technical review of test results for completeness and compliance to ensure the documentation, controls and traceability are in place to maintain integrity.
- Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities.
- Understands and demonstrates aseptic technique.
- Performs equipment validations.
- Support audits by regulatory agencies, such as FDA, Board of Pharmacy, and DEA.
- Bachelor’s Degree in microbiology or science related field
- Sterile compounding and/or use of sterilization equipment experience preferred
- Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls.
- Must exhibit good analytical, writing, interpersonal, and organizational skills.
- Must be able to meet deadlines.
- Must be detail oriented and have multi-tasking capabilities with ability to prioritize.
- Must exhibit strong computer skills especially in Microsoft Excel.
- Must have ability to work in a fast-paced environment.
- Must exhibit excellent problem resolution skills.
- Must be able to work independently, as well as part of a team.
This is a full time position. The benefit plans include, medical, dental, vision, and 401K with a company match. We offer PTO, paid holidays and other company-paid benefits.
Job Status: Full Time