Job Category: Quality
Reason: Special Project
Schedule Notes: 12 hour shifts M-Sun 1st shift--7a-7p M-Sun 2nd shift--3p-3a For Instance in a 2 week period: 1st week- M,T, F, Sat, Sun 2nd week- W & TH
Great opportunity for someone who recently graduated with their BS degree, who is looking to gain valuable industry experience while working onsite at a company that is known for producing high quality life saving therapies and medicines.
This is an entry-level position responsible for performing environmental monitoring of all classified production areas, including sampling of site utility systems.
This position spends at least 50% of their time on the production floor collecting and testing samples.
Environmental Assurance department must maintain adequate staffing to support all operations 24 hours per day, 7 days a week.
- In addition to routine environmental monitoring of the aseptic fill lines, this position is also responsible for executing the Quality Oversight program for the fill lines and also provides quality control approval of air flow visualizations conducted on site.
- Performs biological testing of moderate to advanced complexity within a Quality Operations Laboratory in a safe, accurate, and efficient manner following established written procedures while maintaining complete and accurate records of the work and results.
- This testing is required for the release of raw materials, in-process materials, and final containers.
- Attends required GMP and Safety training courses.
- Demonstrates good work ethics and maintains acceptable attendance
- Learns and develops multitasking skills and good time management
- Conducts all work with a focus on safety, quality, and timely throughput
- Conducts various routine and non-routine biological testing (assays) according to procedure.
- Follows the requirements of Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).
- Maintains complete and accurate records of work performed and test results.
- Calibrates equipment and performs equipment maintenance
- Performs non-routine duties, housekeeping duties, etc. as assigned.
- The Assistant Biologist is expected to recognize 'abnormal' results and to perform some preliminary evaluation of her/his performance of the test procedure.
- The Assistant Biologist consults with Associate Biologists and/or the Laboratory Supervisor on significant problems.
- The solutions to such problems are always within the confines of the test procedures.
- All of the test results of an Assistant Biologist are reviewed by either the Lab Supervisor or a designated Associate Biologist for 'reasonableness' and conformance to the required limit(s).
- No unexpected test result generated by an Assistant Biologist is accepted without an independent confirmation (normally by an Associate Biologist) and review of the results by the Lab Supervisor.
- While this is an entry-level position, the Assistant Biologist is expected to progress to a performance level requiring less direct supervision (either by the Laboratory Supervisor or the assigned Associate Biologist trainer).
- The Assistant Biologist has a variety of weekly & monthly assignments (e.g. preparation of solutions, housekeeping, etc.) that they are expected to accomplish without specific direction to do so.
- An Assistant Biologist participates in Quality Control studies (blind testing series, validation protocols, precision and accuracy studies) of tests for which they are trained.
- Shift work and weekends required depending on specific job assignment.
- Occasional overtime.
- Hep B Vaccination required.
- Associates Degree in a life science field, medical technology, or related and a minimum of 6-months of applicable laboratory experience (paid and/or industry experience)
- BS/BA degree in a life science field, medical technology, or related with 0 years of paid/industry lab experience.