Position Title: QC Microbiology Analyst I
Work Location: Marlborough, MA 01581
Assignment Duration: 06 months
Work Schedule: Standard work week (M-F) with flexibility of weekend work
Work Arrangement: On-site
 
Position Summary: Support Quality Control Microbiological testing of drug substances, raw materials, and process intermediates under cGMP and GLP guidelines, address excursions, and conduct investigations.
 
Key Responsibilities:

• Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.
• Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
• Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
• Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.
• Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.
• Author/update laboratory procedures, protocols, and help in EM data trend reports.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions.
• Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.

 
Qualification & Experience:

• B.S. degree in Biology or other life science related degree with 0-3 years of relevant industry experience in a quality control role.
• While working towards a completed B.S. degree, consideration will be given to associate degree in Biology or related life sciences with 2-5 years direct industry experience.
• Excellent knowledge of Aseptic technique and common microbiological testing.
• Knowledge of relevant, compliance and guidance documents.
• Must be able to gown into cleanrooms in support of testing and manufacturing activities.
• Good documentation (ALCOA +) and data organization.
• Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.
• Interpersonal skills and ability to contribute to the success of a team.
• Proven history of working in a fast-paced team environment, time management, and meet deadlines.
• Team player with the ability and willingness to support other colleagues in the Quality Control department.
• This support may include future cross training with analytical assays as needed.
• Models our Core Values: Bold, Caring, and Results-Driven — consistently exemplifies the culture we strive to create, operates with transparency, and earns trust.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 30.00/hr.