Quality Control Analyst II — Method Transfers & Compliance

Integrated Resources, Inc ( IRI ); Norton (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking an Analyst II for Quality Control Operations to perform routine and non-routine analytical assays and to support development through commercialization. The role includes maintaining training records, data submission, and contributing to method transfers and validation as needed.

The analyst will assist in equipment and inventory maintenance, document control updates, and collaboration with cross-functional teams to ensure on-time delivery within GMP standards.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related field; Associate degree or biotech cert or equivalent considered
• Pharmaceutical/Biotech industry experience with 4–8 years in a regulated laboratory setting, Quality Control, or equivalent
• Data analysis experience preferred
• Ability to work under direction, with attention to detail, in an environment with shifting priorities
• Good communication and teamwork abilities in a collaborative environment
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful

Responsibilities

• Perform routine and non-routine analytical assays for raw materials, in-process samples, product release, and stability studies using established SOPs
• Maintain up-to-date training records, adhere to testing schedule, ensure timely completion of tasks to support QC timelines and quality metrics
• Assist in maintenance of laboratory equipment and inventory, including preparation of reagents and samples
• Ensure data is submitted timely; may qualify as a data reviewer for regulatory submissions
• Perform role-specific operational assignments (e.g., raw material sampling, environmental monitoring, product testing)
• Contribute to updating controlled documents, including SOPs, work instructions, and test methods
• Adhere to internal standards, policies, SOPs, GMP/GLP/ICH guidelines to maintain quality and compliance
• Collaborate with QC and cross-functional teams to support organizational goals
• Pursue ongoing training to deepen QC testing techniques and regulatory compliance
• May assist in data verification for regulatory submissions
• Participate in inspection readiness activities and onsite audits
• Support continuous improvement initiatives to enhance QC processes and efficiency
• Collaborate with Manufacturing, Materials Management, and Quality Assurance to align with business goals

Skills

Data analysis

LIMS

Excel

Communication

Education

B.S. in chemistry/biology/biochemistry

4–8 years QC/regulated lab experience

Tools

Word

PowerPoint

Job description

Alnylam Pharmaceuticals is seeking an Analyst II for Quality Control Operations to perform routine and non-routine analytical assays and to support development through commercialization. The role includes maintaining training records, data submission, and contributing to method transfers and validation as needed.

The analyst will assist in equipment and inventory maintenance, document control updates, and collaboration with cross-functional teams to ensure on-time delivery within GMP standards.