Quality Assurance Specialist

Overview The Specialist, Quality Operations QA is an experienced senior level position within Quality Operations. This position will provide on-site operational support from Monday – Friday during the hours of 8 AM – 4 PM at Alnylam’s Norton Manufacturing Facility. The Specialist role is capable of supporting all aspects of cGMP production. Key Responsibilities * QA review and approval of deviations, CAPAs, change controls, PM Plans, Work Orders * QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch records for all unit operations * Performing Area Clearance, Change over operations and OTF support for manufacturing operations * Independently providing forward processing decisions during manufacturing discrepancies * Lead and own disposition activities for the release of API, DS and DSI * SOP generation and ownership for Quality related functions * Ensure adherence to Quality systems for internal manufacturing facilities * Quality oversight of New Product Introductions / Product Re-introductions * Lead and drive site inspection readiness and provide QA support in partner audits and regulatory inspections * Serves as primary QA contact during Major / Critical manufacturing events * Lead complex cross-functional investigations Qualifications * A minimum of Bachelor’s degree in sciences or engineering * A minimum of 5-8 years of QA operations experience in a GMP manufacturing facility * Experience with Quality oversight in GMP Operations from Early Stage to Commercial * Excellent understanding of FDA, EMA regulations and ICH guidelines * Excellent organizational, communication, and interpersonal skills * Experience with electronic Quality Management Systems #LI-AB1 #LI-Onsite U.S. Pay Range $88,700.00 - $120,100.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers 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.