QC Microbiologist II

Curia • Hopkinton, MA

5d • $74,000 - $85,000 • Onsite

About The Position

The QC Microbiologist II performs quality activities supporting product production and release. The role conducts testing, trending, and reporting to help ensure compliance with applicable regulatory requirements. Based in Hopkinton, Massachusetts, this position supports microbiological quality control activities in a pharmaceutical manufacturing environment.

Requirements

• Bachelor’s degree in a relevant field and at least 3 years of industry experience in a GMP, GLP, or pharmaceutical cleanroom environment; or a master’s degree in a relevant field and 1 year of related work experience.
• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.

Nice To Haves

• Proficiency in validation and qualification of laboratory microbiological techniques.
• Knowledge of FDA cGMPs (21 CFR 211) and ISO 9001, 13485, and 17025.

Responsibilities

• Initiate OOS/OT or Environmental Monitoring Excursion investigations.
• Initiate quality events, including deviations, invalid assay investigations, CAPA, and change controls.
• Perform microbiological testing of water, including endotoxin, bioburden, and TOC testing.
• Perform microbiological testing of raw materials, in-process materials, intermediates, and final products, including endotoxin, sterility, and bioburden testing.
• Perform environmental monitoring in clean rooms under ISO and EU specifications.
• Read, trend, and report environmental, personnel, in-process, raw material, finished product, and water bioburden testing results.
• Prepare and send samples for microbiological identification.
• Maintain historical files on organisms found in classified areas, including microbial identification and trending.
• Perform line-clear and line-start verifications.
• Perform bacteriostasis and fungistasis (B&F), growth-promotion testing of incoming microbiology laboratory media, and other assigned assays for which trained.
• Receive, log in, process, track, and distribute results for QC microbiological samples submitted for internal testing, and close out the samples.
• Assist QC management with authoring, reviewing, and approving documentation.
• Assist QC management with Suite and PW system requalification.
• Perform compendial testing, such as pH, conductivity, and osmolality testing.
• Support raw material handling and testing.
• Support general QC microbiology laboratory activities, including chart reading and changing, equipment cleaning and maintenance, supply and inventory maintenance, and laboratory housekeeping.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level