QC Microbiology Analyst I

Job Title: QC Microbiology Analyst I
Location: West Borough MA
Duration: 6 + months (Possibilities of Extension)
 
Pay Rate: $33.78/hr. on W2
 
Position Summary:
The primary purpose of the Analyst I position is to support Quality Control Microbiological testing of drug substances, raw materials, and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines. The role also involves addressing excursions and conducting investigations.
 
Essential Job Responsibilities:

• Gown for Grade B/A manufacturing areas and collect Environmental Monitoring (EM) samples for:

• Viable air
• Non-viable particulates
• Surface viable samples

• Perform QC testing of samples for:

Bioburden

• Microbial identification
• Growth promotion
• Endotoxin analysis

• Receive manufacturing samples for QC analysis and ship samples to contract laboratories.
• Review data for lot disposition and product release.
• Read and review routine EM plates, lab testing data, logbooks, and documents for release and trending reports.
• Follow aseptic behavior, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and proper documentation standards.
• Author or update laboratory procedures, protocols, and assist in EM data trend reporting.
• Support:

• Cleanroom qualification
• Gowning qualification
• Aseptic process qualification
• Personnel monitoring for manufacturing activities

• Initiate Incident Reports for out-of-specification (OOS) results and collaborate with the team to identify root causes and corrective actions.
• Perform QC lab support activities, including:

• Lab setup and housekeeping
• Instrument maintenance
• Coordination of instrument calibration

 
Required Qualifications:

• Education:

• B.S. degree in Biology or other life science-related field, with 0–3 years of relevant industry experience in a Quality Control role.
• Candidates with an Associate degree in Biology or related life sciences and 2–5 years of direct industry experience will also be considered.

 
Technical Skills:

• Excellent knowledge of aseptic techniques and common microbiological testing methods.
• Knowledge of relevant compliance and regulatory guidance documents.
• Ability to gown into cleanrooms to support testing and manufacturing activities.
• Strong documentation skills (ALCOA+ principles) and data organization.

 

• Work Requirements:

• Ability to work weekends as needed (most of the schedule will be during standard workweek hours).
• Strong interpersonal skills and ability to contribute effectively within a team environment.

 
Preferred Qualifications:

• Proven ability to work effectively in a fast-paced, team-oriented environment.
• Excellent time management and ability to meet deadlines.
• Willingness to support colleagues in the Quality Control department, including potential cross-training with analytical assays as needed.

 
Core Values:
Models our Core Values — Product, Caring, and Results-Driven — by:

• Consistently exemplifying the culture we strive to create.
• Operating with transparency.
• Earning and maintaining trust.

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