Microbiologist
4 weeks ago
We are seeking a highly skilled Microbiologist to join our team at Randstad Life Sciences. As a Microbiologist, you will be responsible for performing microbiological assays of raw materials, production intermediates, and bulk samples, finished products, water testing, comprised air testing, environmental monitoring samples, and process & cleaning validation samples.
Key Responsibilities:
- Perform microbiological assays of raw materials, production intermediates, and bulk samples, finished products, environmental monitoring samples, process & cleaning validation samples, and packaged samples.
- Prepare media following SOPs, perform growth promotion to qualify each batch of media before release for use in testing.
- Perform gram staining, identifying type of bacteria per USP methods.
- Ensure that all test methods follow up-to-date USP methods and customer requirements.
- Communicate any OOSs for Micro immediately to Manager and Director of Quality. Notify operations if there is any impact to bulk or packaging and stop the use of the bulk or the packaging operations until OOS is investigated and confirmed.
- Participate in Micro failure investigations as a member of a cross-functional team.
- Update/author SOPs as needed.
- Perform trending analysis on water, environmental, and comprised air to ensure that systems are in a state of control.
- Perform periodic testing of OTC products placed on real-time stability studies per stability protocol SOP.
- Support regulatory, internal, and customer audits as needed.
- Manage Lab Micro lab supplies ensuring that supplies are ordered on time to prevent any disruptions to the day-to-day activity.
- Create new test methods based on customer and product suitability requirements.
Requirements:
- BS degree required in Biology, Microbiology, Biochemistry, or a relevant science discipline; 5-10 years of relevant Quality experience preferably in the bio/pharmaceutical industry.
- MS degree preferred in Biology, Microbiology, Biochemistry, or a relevant science discipline; 3-5 years of relevant Quality experience preferably in the bio/pharmaceutical industry.
- Experience in FDA regulations and USP Micro test methods.
Skills and Abilities:
- Requires basic knowledge of fundamental quality concepts. Learns and performs defined procedures.
- Working knowledge and practical application of relevant techniques and instrumentation such as aseptic technique, sterilization procedures, inoculation, isolation, gram staining, etc.
- Ability to interpret and document test results according to standard operating procedures and using cGMPs.
- Learns to identify technical problems and solve these under the guidance of management.
- Receives minimal supervision on routine work, and specific direction on new work. Organizes daily activities, including technical aspects, to ensure timely completion of assignments.
- Ability to participate on teams comprised of immediate group members or to work cross-functionally, if necessary.
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