Quality Control Analyst II, Reference Materials

Alnylam Pharmaceuticals; Norton (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biotechnology company located in Norton, MA, is seeking a Quality Control Analyst II to ensure compliance and quality standards in sample management operations. The role involves qualifications of reference materials, data analysis, and collaboration with multiple departments. Candidates should have a B.S. in a relevant scientific field, 3-6 years of experience in a GMP lab, and strong communication skills. This is a full-time, onsite position with opportunities for growth.

Qualifications

• 3-6 years of experience in a regulated laboratory setting.
• Pharmaceutical/Biotech industry experience.
• Ability to work under direction.

Responsibilities

• Assist in the qualification and requalification of reference standards.
• Engage in the collection and analysis of QC data.
• Accurately document results in compliance with GMP standards.

Skills

Attention to detail

Organizational skills

Communication

Teamwork abilities

Knowledge of LIMS

Education

B.S. in chemistry, biology, or biochemistry

Associates Degree or Biotech Certificate

Tools

Microsoft Suite

Job description

Overview

The Quality Control Analyst II, Reference Materials 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 II will assist and participate in the qualification, management, and inventory control of required reference materials.

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.

Responsibilities

• 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.
• 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 3-6 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

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 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.

Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Analyst