Job Title: Quality Lab Associate I , Micro

 

Summary:

Perform functions within the Microbiology Laboratory and/or conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished goods. The duties also include equipment maintenance and LIMS management.

 

Essential Duties and Responsibilities:

Use sophisticated laboratory instruments and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical and aseptic technique skills. Document test data clearly and accurately. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements. Work on special projects and protocol testing that involves new methods and instrumentation. Complete all special projects and protocol testing in a timely and appropriate manner. Investigate deviations and write exception documents. Communicate issues between departments as appropriate. Communicate effectively with co-workers to ensure all required tasks are completed as expected.

Qualifications:

BS/BA Degree in Microbiology or Biology with 0-2 years pharmaceutical microbiology experience. Microbiology coursework and laboratory work utilizing aseptic technique is required. Ability to handle multiple tasks concurrently and complete tasks in a timely fashion. Computer literate. Must be able to communicate effectively across all departments and levels of management. Must have understanding of laboratory instruments and methods. Must have excellent writing skills to write clear and concise reports. Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred.