Quality Control Analyst - Microbiology

The Quality Control Analyst I/II will provide support for environmental monitoring, water system testing, and various Microbiology Laboratory testing activities in compliance with cGMPs.  The position will also maintain the laboratory testing area, equipment, and supporting documentation for routine activities as well as troubleshoot routine issues within the laboratory and provide recommendations to existing procedures to improve efficiencies. This position requires flexibility with changing priorities.

 

Job duties and responsibilities include:

· Performs environmental monitoring in classified cleanroom manufacturing areas

· Samples Water systems and clean steam for bioburden, endotoxin (LAL), conductivity, and TOC analysis

· Performs bioburden and LAL testing of raw materials, in-process materials, and product materials

· General laboratory support activities including reagent preparation, equipment maintenance, growth promotion for media, etc.

· Performs biological indicator testing

· May troubleshoot routine problems related to laboratory procedures, assay performance and data with minimal input from supervisor; may provide recommendations to non-routine issues

·  Completes documentation for EM excursions and follow up testing

·  Coordinates sample submission to contract laboratories for microbial identifications

·  Assists the trending of environmental monitoring and water testing data

· Reports out-of-compliance situations to supervisor

· Provides recommendations to existing procedures to improve efficiencies

· May participate in team meetings with contract manufacturers and collaborators

· May train other analysts to perform various laboratory procedures and assays

· May write/revise SOPs and assist in preparation of protocols and reports

· May perform other routine testing as needed.

 

Education/Certification

Associates degree in a scientific discipline with a minimum of 3-4 years of related experience in a GMP environment. Alternatively, a Bachelor’s degree in a scientific discipline may be substituted for some of the experience.



ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance.  Please send a detailed resume to:  Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: Fax: (781)895-0611; E-mail: resumes@immunogen.com .  Please reference the ad source in your response.

 

 

We are an Equal Opportunity Employer