QC Microbiologist II

Curia • Hopkinton, MA

1d • $74,000 - $85,000 • Onsite

About The Position

The Quality Control Microbiologist II performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Requirements

• Bachelor’s degree in a relevant field and a minimum of 3 years’ industry experience in a GMP, GLP, or pharmaceutical cleanroom environment, OR 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

• Proficient in the validation/qualification of lab microbiological techniques
• Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025

Responsibilities

• Initiate OOS/OT or Environmental Monitoring Excursion Investigations
• Initiate Quality events such as deviations, invalid assay investigations, CAPA and Change controls.
• Perform microbiological testing (endotoxin, bioburden and TOC) for water
• Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
• Perform environmental monitoring of the clean rooms (under ISO and EU specifications)
• Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
• Prepare and send out samples for microbiological identification
• Maintain historical files on organisms found in classified areas; microbial identification and trending
• Perform line clear and line start verifications
• Perform other microbiological assays: Bacteriostasis and Fungistasis (B&F), Growth promotion testing of all incoming media used in the microbiology laboratory, Other tests as trained and assigned
• Receive QC microbiological sample for internal testing, login, processing, tracking, distribution of test results, and closure
• Assist QC management to author, review and approve documentation.
• Assist QC management to perform Suite and PW system requalification.
• Perform compendial testing such as pH, conductivity, and Osmolality etc.
• Support raw material handling and testing.
• Provide Support of general QC Microbiology Laboratory activities, such as: Chart reading and changing, Equipment cleaning and maintenance, Maintaining supplies and inventory, General laboratory housekeeping

Benefits

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

What This Job Offers

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