Quality Control Analyst (Norton)

Quality Control Analyst II ( GMP – Microbiology/Analytical) Pay Rate:

$45.00 per hour (flexible based on experience) or about $92,000 a year Location / Work Arrangement:

Onsite – Norton, MA Job Type:

Long Term Contract Schedule:

Friday–Monday (4 x 10-hour days), Weekend coverage required Initial training will take place Monday–Friday prior to transitioning to the weekend schedule.

Position Overview The Quality Control Operations (QCO) Analyst II Contractor supports the maintenance of high standards of quality and compliance across development through commercialization. This role performs routine and non-routine analytical and microbiological testing, participates in data trending and investigations, supports laboratory operations, and assists with method transfer, qualification/validation, verification, and implementation.

This position plays a critical role in maintaining QC efficiency, ensuring regulatory compliance, and supporting inspection readiness activities.

Key Responsibilities Perform routine and non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies in accordance with SOPs Support weekend laboratory operations and maintain required training documentation Assist with laboratory equipment maintenance, inventory management, reagent preparation, and sample preparation Review analytical data in a timely manner and qualify as a data reviewer Perform operational assignments including raw material testing, environmental monitoring, and in-process testing Contribute to the creation, revision, and maintenance of controlled documents (SOPs, work instructions, and test methods) Ensure compliance with internal policies, SOPs, and applicable regulatory standards (GMP, GLP, ICH) Participate in continuous improvement initiatives and cross-functional collaboration Support regulatory submissions, audit readiness, and inspection activities

Qualifications Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific discipline 4–8 years of pharmaceutical or biotechnology experience in a GMP Quality Control environment (or equivalent combination of education and experience) Experience with method transfer and implementation; understanding of method lifecycle management preferred Experience with microbiology and environmental monitoring strongly preferred Familiarity with BioBuilder programs a plus Working knowledge of LIMS systems, preferably LabWare Proficiency in Microsoft Excel, Word, and PowerPoint Strong technical writing, data analysis, problem-solving, and organizational skills Excellent communication skills and ability to work effectively in a team-based environment