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 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.
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.
