Quality Control Analyst II

Quality Control Technical Operations Analyst II

The Quality Control Technical Operations (QCO) Analyst II plays a 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 may participate in data trending, investigations, and laboratory operations. This position may play a role in method transfers, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed within project milestones and timelines, the Analyst II 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. There may occasional responsibilities at a secondary location in Cambridge, MA.

Key Responsibilities (including but not limited to):

• Perform routine and non-routine analytical assays, with increasing complexity, to support raw materials, in-process samples, product release, and stability studies, following established SOPs
• 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
• Ensure data is submitted timely; may qualify as a data reviewer to ensure timely and efficient data availability.
• Perform role-specific operational assignments (e.g., raw material sampling and testing, environmental monitoring, product 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 ALNY 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.
• 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 and regulatory compliance.
• May assist in data verification for regulatory submissions.
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
• Support continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Collaborate with other organizational functions including Manufacturing, Materials Management, and Quality Assurance to ensure alignment with overall business goals.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field; Associates Degree, Biotech Certificate, or equivalent considered
• Pharmaceutical/Biotech industry experience with 4-8 years in a regulated laboratory setting, Quality Control, or equivalent, relevant experience
• Data analysis experience preferred
• Ability to work under direction, with attention to detail, in an environment where priorities shift
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful