Quality Control Analyst I

Quality Control, Analyst I

Overview

The Quality Control Analyst I in support of QC Raw Materials/Sample Management (QC-RMSM) plays a crucial role in sample management operations for our internal and external GMP laboratories. This role ensures high standards of quality and compliance are met in support of early-stage development through commercial Alnylam programs. The QC-RMSM Analyst I will assist and participate in the qualification, management, and inventory control of required reference materials as well as the Raw Material program.

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):

• Assist in the qualification and requalification of primary, secondary and working reference standards as well as critical reagents
• Engage in the collection, analysis, and review of QC data to ensure availability of data
• 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 program, including inspection of incoming raw materials
• Collaborate cross-functionally with other organizational functions including those in Quality Control, Quality Assurance, and CMC to ensure reference material availability and 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 0-4 years in a regulated laboratory setting, Quality Control, or equivalent relevant experience with reference material lifecycle.
• Ability to work under direction, with attention to detail and strong organizational skills, in an environment where priorities shift
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment
• Knowledge of LIMS and Microsoft Suite of Applications is helpful

#LI-AB1 #LI-Onsite

U.S. Pay Range

$61,500.00 - $83,300.00

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.