Microbiology Technician

Primary Duties and Responsibilities

* Perform microbiology & particulate testing of product and processes (clean room, WFI loop) by accurately following all testing as specified by the appropriate quality documentation.

* Perform environmental monitoring in manufacturing areas, including tracking & trending test results and performing bioburden sampling in controlled areas.

* Assist in investigations related to Lab OOS (Out of Specification) and support Production OOS investigations.

* Support plant and customer quality continuous improvement teams.

* Assist in the equipment qualification for the new quality lab.

* Assist in method transfer & method validation.

Required Qualifications

* BS Degree (Microbiology preferred) plus minimum 1 to 3 years' experience in a cGMP lab.

* Sterile pharmaceutical manufacturing environmental monitoring experience a plus.

* Experience with cGMP guidelines and ability to follow complicated procedures and work instructions.

* Proficiency in Excel, Word and PowerPoint.

* Availability to work overtime and weekends as needed.

Skills/Abilities

* Good analytical skills.

* Self-Starter with good written and communication skills.

* Detail oriented and rigorous.

* Knowledge of ISO, GMPs, CFR 21 regulations