Quality Lab Associate II, Micro

OVERVIEW Conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished products as well as water system testing. Execute test method validation under the direction of supervision.

Write/revise standard operating procedures, forms, protocols, and investigation reports. The duties also include equipment maintenance and LIMS management. RESPONSIBILITIES Use sophisticated laboratory instruments and computer systems to collect and record data.

Perform advanced laboratory assays requiring precise analytical and aseptic technique skills. Perform review of test data, which includes overall documentation practices. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements.

Execute test method validation for new active pharmaceutical ingredients and finished drug products. Support GMP equipment qualification testing and laboratory equipment validation testing. 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 laboratory investigation reports for OOS results. Write/revise standard operating procedures, forms, and protocols.

Communicate issues to supervision and between departments as appropriate. Communicate effectively with co-workers to ensure all required tasks are completed as expected. Cross-train within different groups in the microbiology laboratory.

QUALIFICATIONS BS/BA Degree in Microbiology or Biology with 2 - 5 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 scientifi Location: