
Job Overview
Employment Type
Full-time
Compensation
Salary
Range $74,000.00 - $85,000.00
Benefits
Generous benefit options
Paid training
vacation
Paid holidays
Career advancement opportunities
Education Reimbursement
401k Program with matching contributions
Job Description
Curia is a leading global contract development and manufacturing organization (CDMO) with more than 30 years of experience collaborating with pharmaceutical and biotechnology companies to deliver life-saving treatments to patients worldwide. Known for its dedication to quality, innovation, and advancing healthcare, Curia has built a reputation as a trusted partner in the pharmaceutical industry. The company offers comprehensive solutions ranging from drug development through to commercial manufacturing, helping to bring novel therapies from the laboratory to the market efficiently and safely. Curia places a strong emphasis on compliance with regulatory standards, continuous improvement, and fostering a work environment that encourages growth, learning, and career advancement for its employees. The organization is committed to employing top talent and fostering diversity and inclusion within its workforce.
The position of Quality Control (QC) Microbiologist II at Curia, located in Hopkinton, Massachusetts, is a critical role within the company's quality assurance framework. This full-time role offers a competitive salary range of $74,000 to $85,000 per year, considering education, experience, and internal equity. The QC Microbiologist II is responsible for performing a variety of microbiological testing activities to support product production and release. Their role is integral in ensuring compliance with applicable regulatory requirements such as FDA cGMPs, ISO standards, and other quality systems. The QC Microbiologist II will conduct testing for endotoxin, bioburden, total organic carbon (TOC), sterility, and environmental monitoring under ISO and EU specifications.
The successful candidate will also initiate and manage quality events including out-of-specification (OOS)/out-of-trend (OOT) investigations, deviations, CAPAs (Corrective and Preventive Actions), and change controls. They assist in sample handling, logging, processing, and reporting, as well as maintaining historical records for microbial identification and trending. Additional duties include validation and qualification of microbiological methods, supporting raw material handling and testing, and performing general laboratory tasks such as equipment maintenance, cleaning, and inventory management.
Curia offers extensive benefits starting from the first day of employment including paid training, vacation and holidays, education reimbursement, 401K with matching, and career development opportunities. This role provides the opportunity to be part of a mission-driven organization where your efforts directly impact patient lives by ensuring the safety and quality of pharmaceutical products. As an integral member of the team, the QC Microbiologist II will work in a regulated environment promoting continuous learning and professional growth, providing a robust platform for advancing their career in pharmaceutical quality control microbiology.
The position of Quality Control (QC) Microbiologist II at Curia, located in Hopkinton, Massachusetts, is a critical role within the company's quality assurance framework. This full-time role offers a competitive salary range of $74,000 to $85,000 per year, considering education, experience, and internal equity. The QC Microbiologist II is responsible for performing a variety of microbiological testing activities to support product production and release. Their role is integral in ensuring compliance with applicable regulatory requirements such as FDA cGMPs, ISO standards, and other quality systems. The QC Microbiologist II will conduct testing for endotoxin, bioburden, total organic carbon (TOC), sterility, and environmental monitoring under ISO and EU specifications.
The successful candidate will also initiate and manage quality events including out-of-specification (OOS)/out-of-trend (OOT) investigations, deviations, CAPAs (Corrective and Preventive Actions), and change controls. They assist in sample handling, logging, processing, and reporting, as well as maintaining historical records for microbial identification and trending. Additional duties include validation and qualification of microbiological methods, supporting raw material handling and testing, and performing general laboratory tasks such as equipment maintenance, cleaning, and inventory management.
Curia offers extensive benefits starting from the first day of employment including paid training, vacation and holidays, education reimbursement, 401K with matching, and career development opportunities. This role provides the opportunity to be part of a mission-driven organization where your efforts directly impact patient lives by ensuring the safety and quality of pharmaceutical products. As an integral member of the team, the QC Microbiologist II will work in a regulated environment promoting continuous learning and professional growth, providing a robust platform for advancing their career in pharmaceutical quality control microbiology.
Job Requirements
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- Bachelor's degree in a relevant field or Master's degree as specified
- Minimum 3 years' relevant industry experience or 1 year with Master's degree
- Experience in GMP, GLP, or pharmaceutical cleanroom environment
- Ability to perform microbiological testing and investigations
- Familiarity with regulatory standards such as FDA cGMPs and ISO standards
Job Qualifications
- 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
- Proficient in the validation/qualification of lab microbiological techniques
- Knowledgeable in FDA cGMPs (21 CFR 211), ISO 9001, 13485 and 17025
- Strong analytical and problem-solving skills
- Excellent documentation and communication skills
Job Duties
- 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 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
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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