Quality Control Analyst II

The Quality Control Operations (QCO) Analyst II plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to executing routine and non-routine testing in support of development through commercial programs, the Analyst II will also participate in data trending, investigations, and laboratory operations. This position will also play a role in method transfers, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed with precision, the Analyst II significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.

This position is onsite and will be primarily located in Norton, MA, with potential occasional responsibilities at other Alnylam locations. The role requires flexibility for weekend coverage to support a continuous operational schedule. This is a first shift position Friday to Monday from 8-6PM (4 x 10 hours), but will require an initial period of Monday-Friday work to accommodate training.

• Perform routine and non-routine analytical and/or microbiological assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
• Support a continuous operational schedule by supporting weekend laboratory operations (Analytical, Microbiology, Raw Materials).
• 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
• Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
• Perform role-specific operational assignments (e.g., raw material processes including SAP transactions, environmental monitoring, in-process testing, etc.).
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.
• Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective Alnylam goals
• Pursue ongoing training and development to deepen expertise in QC testing techniques, TOQ operations, and regulatory compliance.
• May assist in data verifications for regulatory submissions.
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Collaborate with other organizational functions including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance to ensure alignment with overall business goals.

• B.S. in chemistry, biology, or biochemistry, or related scientific field;
• Pharmaceutical/Biotech industry experience with 4 years in a GMP Quality Control function or equivalent, relevant industry experience
• Preferred experience in method transfer and/or analytical method implementation
• Data analysis experience preferred
• Solid problem-solving skills and experience in conducting investigations and implementing CAPA
• Ability to work under direction, with attention to detail, in environments where priorities shift
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment
• Knowledge of LabWare LIMS, Excel, Word, and PowerPoint preferred

U.S. Pay Range

$71,400.00 - $96,600.00

The pay range reflects the hourly wage 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. Pay range does not include shift differential pay if applicable. 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

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach 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 possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel 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.