QC Analyst

A biopharmaceutical company is seeking a highly motivated QC Analyst for their office location in the Woburn, MA area.

Responsibilities:

The QC Analyst will:

• Perform routine Quality Control microbiology testing including, but not limited to bioburden testing, plate reading, endotoxin testing, total organic carbon testing, conductivity testing, media growth promotion, and microbial identification testing.


• Support routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management).


• Ensure laboratory operational readiness and assist with troubleshooting/continuous improvement as needed.


• Revise SOPs, forms, protocols, data reports, and other controlled documents relating to QC microbiology testing and instrumentation.


• Perform peer review of both internal and externally generated data, as needed.


• Support QC deviations, investigations, root cause analysis, change control, and CAPA as needed.

Qualifications:

• BS or MS in Microbiology or a related discipline with 0-2 years industry experience.


• Hands-on experience with performing microbiological analytical testing (bioburden, endotoxin, TOC, etc..) preferred.


• Independently motivated and detail-oriented with good problem-solving ability.


• Strong oral and written communication skills with clear penmanship.


• Experience with Excel and Microsoft Word.


• Ability and desire to work in a fast-paced, start-up environment.


• Strong collaboration skills.


• Shift: 9:30 AM - 6:00 PM, Monday - Friday.


• Flex hours and occasional weekend work.