Senior Associate Quality Assurance Operations

Overview

The Senior Associate, Quality Operations QA will provide on site QA Operational support from Monday – Friday during the hours of 8 AM – 4 PM at Alnylam’s Norton Manufacturing Facility. This role will support on the floor manufacturing operations, Batch Disposition and Release as well as Audits and Inspections. The position will perform area and equipment change overs, perform batch record review, disposition of API and/or Raw Material and triage deviation events to enable manufacturing operations to continue uninterrupted.

Key Responsibilities

• QA review and approval for deviations, CAPAs, change controls, PM Plans, Work Orders
• QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch record review/approval, and raw material disposition process
• Performing Area Clearance and Change over operations for manufacturing facility
• Lead disposition of Active Pharmaceutical Ingredients
• SOP generation and ownership for Quality related functions
• Ensure adherence to Quality systems for internal manufacturing facilities
• Partnering with the internal cross functional groups at the Norton facility to develop and maintain the programs through SOP creation and revision process
• Provide QA support in partner audits and regulatory inspections

Qualifications

• A minimum of Bachelor’s degree in sciences or engineering
• A minimum of 3 years of QA operations experience in a GMP manufacturing facility
• Experience in Early Phase Clinical GMP Operations
• Excellent understanding of FDA, EMA regulations and ICH guidelines
• Excellent organizational, communication, and interpersonal skills
• Experience with electronic Quality Management Systems
• Experience with electronic enterprise resource planning systems
• Experience with electronic calibration and maintenance systems

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.