Quality Control Analyst II

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

Benefits offered by this job

Paid time off

Health/dental/vision benefits

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corp is seeking a Quality Control Analyst II to perform environmental monitoring, RODI water sampling, and a range of QC assays in ISO-classified cleanrooms. This on-site role supports deviations, investigations, and trend evaluations while adhering to SOPs and GMP-like practices.

The candidate should have a Bachelor’s degree in a scientific discipline and 2+ years of QC laboratory experience, with familiarity in ISO 14644 cleanroom practices.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, or a related scientific discipline required.
• 2+ years of Quality Control laboratory experience preferred.

Responsibilities

• Perform routine environmental monitoring of ISO-classified cleanrooms and controlled environments, including data collection and trend analysis.
• Test RODI water and perform pH, conductivity, endotoxin, and bioburden assays.
• Document results accurately and review deviations, out-of-specification results, and investigations.
• Support SOP creation, review, and implementation of QC and cleanroom procedures.
• Assist in environmental trend evaluations and continuous improvement activities.

Education

Bachelor’s degree in Biology/Microbiology/Chemistry or related scientific discipline

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

• 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.

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 elevate 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.

Thank you for your interest in Repligen! Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing - and to help our customers make a difference in the world.