Quality Control Analyst II
About The Position
The Quality Control Analyst II performs environmental monitoring, RODI water sampling and testing, microbiological and analytical QC assays, documentation review, and supports deviations, out-of-specification results, environmental excursions, investigations, and trend evaluations. The work is conducted in accordance with approved SOPs, ISO 14644 cleanroom controls, and the company’s ISO 9001 Quality Management System. The role supports routine QC laboratory operations within ISO-classified cleanrooms and controlled laboratory environments and reports directly to the Quality Control Manager. This is a 100% on-site 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 focuses on cost and process efficiencies and delivers technologies and solutions intended to set new standards in bioprocessing.
Requirements
- Bachelor’s degree in Biology, Microbiology, Chemistry, or a related scientific discipline.
- 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 efficiently within an ISO 9001 Quality Management System, follow approved procedures, and maintain accurate, compliant records.
- Strong attention to detail and 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 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.
- Ability to bend, reach, stand, walk, or sit regularly during the workday.
- 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 cleanroom and controlled environments, including collecting, documenting, and reviewing 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.
Benefits
- Paid time off
- Health, dental, and vision benefits
- Retirement benefits
- Flexible spending accounts
- Participation in a variable cash program (bonus or commission)
- Equity may be included for eligible roles
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
