QC Raw Materials Analyst II

About the role

This onsite position supports the department’s efforts to maintain the highest standards of quality and compliance from development through commercialization. The role involves testing, evaluation, and release of raw materials to ensure compliance with regulatory requirements, internal specifications, and industry standards. The Analyst II ensures timely and accurate testing of incoming raw materials, maintains documentation, and contributes to continuous improvement initiatives within the laboratory. The primary location is Norton, MA, with occasional responsibilities at a secondary location in Cambridge, MA or off-shift as required by business need.

Responsibilities

• Perform routine and non-routine inspection of raw materials.
• Maintain up-to-date training records, adhere to the inspection schedule, and ensure the timely completion of all assignments to support seamless QC operations and project timelines.
• Accurately document all results in laboratory notebooks, LIMS, or other controlled systems in compliance with GMP standards.
• Review documentation as needed to ensure timely and efficient material availability.
• Participate in raw material qualification programs, including vendor/supplier qualification and material risk assessments.
• Collaborate cross-functionally with Manufacturing, Materials Management, and Quality Assurance to ensure raw material availability and release timelines.
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance.
• Participate in inspection readiness activities and support onsite audits and inspections as needed.

Requirements

• B.S. in chemistry, biology, biochemistry, or a related scientific field; Associates Degree, Biotech Certificate, or equivalent considered.
• 3–6 years of pharmaceutical/biotech industry experience in a regulated laboratory setting, Quality Control, or equivalent relevant experience.
• Ability to work independently with attention to detail in an environment where priorities shift.
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment.
• Ability to stand for extended periods and occasionally lift raw materials (up to 25 lbs).
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful.

Pay

Pay ranges between $38–$42 per hour based on experience.