

New · posted Oct 19
Repligen · Biotechnology
Quality Control Analyst II
- Marlborough, MA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
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.
What you need
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 escalate 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.
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.
Pay and benefits
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..
Paid time off
Health/dental/vision
Retirement benefits
Flexible spending accounts
Bonus or commission programs
Equity eligibility
Where you'll work
Marlborough, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Marlborough, MAJob intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in Massachusetts23 roles publishing pay
Associate & Specialist roles in the US111 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $64,480 | — | $64,480 |
| Massachusetts (middle half) | $60,750 | $75,000 | $82,000 |
| All US (middle half) | $48,000 | $59,000 | $76,000 |
This role: Repligen's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 306 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Repligen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs15
- Lab testing and methods14
- Investigations and CAPA3
- Quality systems and risk3
- GMP and compliance2
- Collaboration and leadership2
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Repligen on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 4
- Locations
By discipline
- Quality5 83%
- Compliance & Safety1 17%
By level
- Senior & Principal3 50%
- Associate & Specialist2 33%
- Manager1 17%
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Quality Control Analyst II at Repligen
Open until filled. $64K a year, employer provided.

