Quality Control Analyst I/II-Microbiology

85 Dan Road, Canton, Massachusetts, 02021, United States

Job Req code 169

Category: Quality

The purpose of this position is the performance and reporting of microbiological testing for product release as well as environmental monitoring of all areas of the manufacturing facility, water sample collection and testing, compilation and entry of environmental monitoring data.  The position ensures that the company goals for timely product testing are accomplished by being directly involved in the production of test results for product release and investigations. Other responsibilities or tasks as deemed necessary from time to time by the area’s supervisor. Some holiday work required.

Key Responsibilities:

• Perform routine Environmental Monitoring (EM)

• Compilation and entry of EM data. 

• Reviewing of EM Data

• Perform safety testing for product release and other related testing

• Recording and reviewing of daily monitoring data for laboratory equipment.  

• Performing the required testing per protocols.

• Revising of Standard Operating Procedure (SOP) as required



Preferred Education and Experience:

  • AS or BS degree in a Biology, Chemistry or equivalent QC related and
  • One (1) or more years experience in a GMP or similarly regulated environment such as a pharmaceutical drug manufacturing, Biologics or Biotechnology company 

Other Skills/Abilities:

• Handling biohazardous materials and chemicals

• Basic laboratory safety procedures

• Knowledge of cGMP and GLP regulations and compendial requirements

• Proficiency with the computer software necessary to perform data handling tasks as well as accessing e-mail and filling out timesheet reports. (Microsoft Excel, Word, Outlook and Access)

• Good communication skills both written and verbal 

• Experience with in testing techniques such as Environmental Monitoring (EM), Bioburden, Endotoxin, Sterility, and Bacteriostatis/Fungistasis testing

Physical Demands:

• Requirements include following gowning procedures, usually lab coats, gloves and sleeves.  

• The working environment includes working with chemicals such as strong acids and bases and will also involve exposure to human tissue products.

issue products.