Quality Control Analyst II, Raw Materials

Role Summary

This on-site role supports quality and regulatory compliance from development through commercialization, performing testing, evaluation, and release of raw materials used in manufacturing to ensure compliance with regulatory requirements and internal specifications. The Analyst II ensures timely and accurate testing of incoming raw materials, maintains documentation, and contributes to continuous improvement initiatives within the laboratory. Primary location is Norton, MA, with occasional responsibilities at Cambridge, MA or off-shift as required by the business need.

Responsibilities

• Perform routine and non-routine inspection and analysis of raw materials using techniques such as HPLC, GC, FTIR, UV, wet chemistry, and other relevant methods.
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics.
• Accurately document all results in laboratory notebooks, LIMS, or other controlled systems in compliance with GMP standards. May qualify as a data reviewer to ensure timely and efficient data availability.
• Participate in raw material qualification programs, including vendor/supplier qualification and material risk assessments.
• Collaborate cross-functionally with other organizational functions including 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 with ALNY requirements
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field; Associates Degree, Biotech Certificate, or equivalent considered
• Pharmaceutical/Biotech industry experience with 3-6 years in a regulated laboratory setting, Quality Control, or equivalent, relevant experience
• Ability to work under direction, 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 of time and occasionally lift raw materials (up to 25lbs)
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful