Conduct critical microbiological analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. Work under minimum supervision.  Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

1) Conduct critical microbiological analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. Work under minimum supervision.

2) Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles.

3) Complete all testing, including special project / protocol testing in a timely and appropriate manner.

4) Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

5) Investigate deviations and write exception documents.

6) Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

7) Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

This position will support the Weekend Shift

Bachelor’s Degree in Biology, Microbiology, or Chemistry with Analytical Chemistry or Laboratory coursework and 0-2 years' experience.

Ability to handle multiple tasks concurrently, and in a timely fashion. Computer literate. Must be detail oriented, conscientious and have high reading comprehension skills. Must have basic understanding of laboratory instrumentation. Must be able to communicate effectively with supervisors and peers.