Quality Control Analyst II

Repligen Corporation • Marlborough, MA

6d • Onsite

About The Position

The Quality Control Analyst II performs environmental monitoring, RODI water sampling and testing, microbiological and analytical QC assays, and documentation review. The role supports 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 analyst 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% onsite position.

The company’s mission is to inspire advances in bioprocessing as a trusted partner in producing biologic drugs that improve human health worldwide. It delivers technologies and solutions intended to improve cost and process efficiencies and set new standards in bioprocessing.

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, or a related scientific discipline required.
• Strong 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 and testing, pH, conductivity, bioburden, endotoxin, and related QC laboratory testing.
• Strong aseptic technique and ability to consistently follow gowning, cleaning, sampling, laboratory safety, and contamination control procedures.
• Ability to work within an ISO 9001 Quality Management System while following approved procedures and maintaining accurate, compliant records.
• Strong attention to detail and demonstrated ability to complete documentation accurately 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.
• 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 escalate issues appropriately.
• 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.

Nice To Haves

• Two or more years of Quality Control laboratory experience, or an equivalent combination of education and experience.
• Experience working in ISO-classified cleanroom environments, including ISO Class 7 and/or ISO Class 8 areas.
• Experience supporting deviations, out-of-specification results, environmental excursions, investigations, and trend evaluations.
• Experience mentoring, training, or providing technical guidance to junior analysts.
• Experience with equipment qualification or validation activities, SAP, CaneaOne, or other quality and documentation systems.

Responsibilities

• Perform routine environmental monitoring of ISO-classified cleanrooms and controlled environments, including collecting, documenting, and reviewing data to support trend analysis.
• Collect and test RODI water samples according to 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.

Benefits

• Paid time off
• Health benefits
• Dental benefits
• Vision benefits
• Retirement benefits
• Flexible spending accounts
• Eligible employees may participate in a variable cash program (bonus or commission); eligible roles may receive equity as part of the compensation package.

What This Job Offers

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