Quality Control Analyst II

Repligen Corporation; Marlborough (MA); On-site; USD 43,000 - 52,000; Full time

Job summary

Repligen Corporation in Marlborough, MA is seeking a Quality Control Analyst II to support environmental monitoring, RODI water sampling, and QC testing within ISO-classified cleanrooms. The role reports to the Quality Control Manager and requires meticulous documentation and adherence to SOPs and ISO 9001 standards.

Responsibilities include environmental data collection, routine QC assays (pH, conductivity, endotoxin, bioburden), trend evaluations, and investigations.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry or related scientific discipline.
• 2+ years of Quality Control laboratory experience or equivalent.
• Experience in ISO-classified cleanroom environments and GMP/ISO standards.

Responsibilities

• Perform environmental monitoring of ISO-classified cleanrooms and controlled environments, including data collection and trend analysis.
• Collect and test RODI water samples per approved procedures.
• Conduct routine QC testing (pH, conductivity, endotoxin, bioburden) and related assays.
• Document results accurately and maintain controlled records per SOPs and GMP practices.
• Support deviations, out-of-spec results, excursions, investigations, and trend evaluations as needed.
• Review peer documentation and data for completeness and compliance.
• Assist in SOP creation, revision, and implementation of lab procedures.

Skills

Environmental monitoring

Documentation

Aseptic technique

Attention to detail

Independent worker

Education

Bachelor's degree in Biology, Microbiology, Chemistry

Tools

SAP

CaneaOne

Job description

The Quality Control Analyst II role is responsible for performing environmental monitoring, RODI water sampling and testing, microbiological and analytical QC assays, documentation review, and support of deviations, out-of-specification results, environmental excursions, investigations, and trend evaluations in accordance with approved SOPs, ISO 14644 cleanroom controls, and the company’s ISO 9001 Quality Management System. The Quality Control Analyst II reports directly to the Quality Control Manager and supports routine QC laboratory operations within ISO-classified cleanrooms and controlled laboratory environments. This is a 100% on site position.

Primary responsibilities include:

• Perform routine environmental monitoring of ISO-classified cleanroom and controlled environments, including collection, documentation, and review of data to support trend analysis.
• Collect and test RODI water samples in accordance with approved procedures and established testing requirements.
• Perform routine QC laboratory testing, including pH, conductivity, endotoxin, bioburden, and related microbiological or analytical assays.
• Accurately document test results, sample collection details, observations, and anomalies in controlled records using good documentation practices.
• Follow approved SOPs, work instructions, laboratory safety practices, gowning requirements, and contamination control procedures.
• Initiate, write, review, and support deviations, out-of-specification results, environmental excursions, and related laboratory investigations as assigned.
• Review peer documentation, laboratory data, and controlled records for completeness, accuracy, and compliance with approved procedures.
• Support SOP creation, revision, periodic review, and implementation of controlled laboratory and cleanroom procedures.
• Support cleanroom monitoring program maintenance, environmental trend evaluations, and continuous improvement activities as needed.

Qualifications and Skills:

• Bachelor’s degree in Biology, Microbiology, Chemistry, or a related scientific discipline required; 2+ years of Quality Control laboratory experience, or equivalent combination of education and experience, preferred.
• Experience working in ISO-classified cleanroom environments, including ISO Class 7 and/or ISO Class 8 areas, preferred.
• Working knowledge of ISO 14644 cleanroom practices, contamination control expectations, environmental monitoring requirements, and routine cleanroom behavior.
• Hands-on experience performing environmental monitoring, RODI water sampling/testing, pH, conductivity, bioburden, endotoxin, and related QC laboratory testing.
• Strong aseptic technique with the ability to consistently follow gowning, cleaning, sampling, laboratory safety, and contamination control procedures.
• Ability to work efficiently within an ISO 9001 Quality Management System while following approved procedures and maintaining accurate, compliant records.
• Strong attention to detail with demonstrated ability to complete documentation accurately and in accordance with approved SOPs, work instructions, and good documentation practices.
• Ability to review laboratory data, test results, and controlled records for completeness, accuracy, and compliance.
• Experience supporting deviations, out-of-specification results, environmental excursions, investigations, and trend evaluations preferred.
• Effective written and verbal communication skills, including the ability to clearly document results, write reports, and collaborate cross-functionally.
• Ability to work independently once trained, prioritize daily laboratory activities, and escalat issues appropriately.
• Experience mentoring, training, or providing technical guidance to junior analysts preferred.
• Experience with equipment qualification/validation activities, SAP, CaneaOne, or other quality and documentation systems preferred.

Work Experience Requirements:

• Experience working in ISO-classified cleanroom environments, including ISO Class 7 and/or ISO Class 8 areas, preferred.
• Working knowledge of ISO 14644 cleanroom practices, contamination control expectations, environmental monitoring requirements, and routine cleanroom behavior.
• Hands-on experience performing environmental monitoring, RODI water sampling/testing, pH, conductivity, bioburden, endotoxin, and related QC laboratory testing.
• Strong aseptic technique with the ability to consistently follow gowning, cleaning, sampling, laboratory safety, and contamination control procedures.
• Ability to work efficiently within an ISO 9001 Quality Management System while following approved procedures and maintaining accurate, compliant records.
• Strong attention to detail with demonstrated ability to complete documentation accurately and in accordance with approved SOPs, work instructions, and good documentation practices.
• Ability to review laboratory data, test results, and controlled records for completeness, accuracy, and compliance.
• Experience supporting deviations, out-of-specification results, environmental excursions, investigations, and trend evaluations preferred.
• Effective written and verbal communication skills, including the ability to clearly document results, write reports, and collaborate cross-functionally.
• Ability to work independently once trained, prioritize daily laboratory activities, and escalat issues appropriately.
• Experience mentoring, training, or providing technical guidance to junior analysts preferred.
• Experience with equipment qualification/validation activities, SAP, CaneaOne, or other quality and documentation systems preferred.

Physical Requirements:

• Regularly required to bend, reach, stand, walk or sit daily
• Ability to move and lift objects up to 50 pounds, with assistance or other aids where appropriate.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing.

The estimated hourly rate/salary range for this role, based in the United States of America is $31/Hr,-$38/Hr..

Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.