QC Analyst

Conducts routine and non-routine microbiological testing of raw materials, stability samples and in-process and finished formulations according to standard operating procedures. Performs organism identification and reads and interprets microbiological cultures and other related tests which may include but not be limited to environmental monitoring, sterility tests, growth promotion, microbial limits test and antimicrobial effectiveness tests. Performs environmental monitoring and processes the data to compile environmental monitoring status reports. Calibrates and maintains laboratory equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed.

Responsibilities:

• Microbiological testing of in-process, development, stability, raw materials and final product samples.

• Environmental monitoring including air viable, surface viable and total particulate during routine monitoring and dynamic fill/finish procedures.

• Water monitoring including collection and Endotoxin, Total Organic Carbon, Bioburden and Conductivity analysis.

• Final buffer release testing including Osmolality, Conductivity, Endotoxin and pH.

• Sterility testing using direct inoculation and membrane filtration methods and Endotoxin testing by chromogenic method for in-process, stability and final product samples.

• Biological indicator testing.

• Growth promotion testing.

• Performance of testing in accordance with standard operation procedures.

• Maintain proficiency in aseptic processing and clean room behaviors

• Environmental data entry and trend analysis

• General laboratory support, including but not limited to sample receipt, inventory control, reagent preparation and equipment, instrument maintenance and media growth promotion testing.

• Revision and development of standard operating procedure as needed.

• Peer training and data review

• Perform job function in accordance with our Quality Policy and Manual as appropriate.

Specific skills relevant to the job:

• Experience with Microbiologic laboratory including environmental and water monitoring. Experience with water testing techniques.

• Individual must be flexible, work well in a team environment and possess developed organizational skills.

• Prior knowledge of aseptic processing, media fills, biopharmaceutical manufacturing and clean room environment preferred.

• Prior knowledge of cGMPs.

Education and Experience:

• Requires Bachelor’s degree in a scientific discipline or equivalent

• Minimum 3-5 years relevant microbiology experience in a GMP and clean room environments

Job Type: Temporary

Pay: From $35.00 per hour

Benefits:

• Tuition reimbursement

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Lexington, MA 02421: Reliably commute or planning to relocate before starting work (Required)

Experience:

• QC microbiology: 1 year (Required)
• cleanroom environmental monitoring: 1 year (Required)

Work Location: One location