Quality Control Analyst II, Raw Materials

This role is considered On-Site.

Overview

The Quality Control Raw Materials (QCRM) Analyst II plays a role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. This includes testing, evaluation, and release of raw materials used in manufacturing to ensure compliance with regulatory requirements, internal specifications, and industry standards. By ensuring these critical activities are executed within project milestones and timelines, the Analyst II contributes to manufacturing operations by ensuring timely and accurate testing of incoming raw materials, maintaining documentation, and contributing to continuous improvement initiatives within the laboratory.

This position is onsite and will be primarily located in Norton, MA. There may occasionally be responsibilities at a secondary location in Cambridge, MA or off-shift as required by business need.

Key Responsibilities (including but not limited to):

• 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

About Alnylam: We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.