Quality Control Microbiology Team Lead

 

•   Supports manufacturing by performing environmental monitoring, plate enumeration and gram

stains, vial inspection, and other routine laboratory activities 

•   Understands the principles of an environmental monitoring program and/or laboratory testing

including, but not limited to: Endotoxin, Mycoplasma, Sterility, and growth promotion

•   Acts a backup to the supervisor when needed

•   Performs qualification testing for laboratory assays or environmental monitoring

•   Performs training for specific testing and monitoring activities

•   Orders, receives, and stores EM and laboratory supplies

•   Accurately reviews data 

•   Participates in scheduling tasks

•   Performs data/statistical analysis, data trending, reporting results and presenting data in group and client meetings.

•   Excellent writing skills. Ability to draft Standard Operating Procedures (SOPs), protocols, reports, etc. Ability to write deviations, EARs, OOS reports, CAPAs.

•   Participates in company sponsored training

•   Interact closely with other departments to ensure efficient, compliant and timely execution of project activities

•   Other duties as assigned

 

•   Bachelor's degree or equivalent experience required. 

•   2-3 years' work experience in a regulated environment preferred

•   cGMP or work experience in a regulated environment preferred

•   Prior pharmaceutical, CMO, CDMO and hazardous goods experience preferred

•   Gown Qualification/Gown Certification Experience Preferred

•   Aseptic technique/handling

•   Experience with Microsoft Word, Excel and Outlook preferred

 

The pay range for this position is $56,193 - $71,200. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.