Quality Control Analyst II, Reference Materials

Role Summary

The Quality Control Analyst II, Reference Materials supports QC Raw Materials/Sample Management (QC-RMSM) and plays a crucial role in sample management operations for internal and external GMP laboratories. This role ensures high standards of quality and compliance are met in support of early-stage development through commercial 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 in Norton, MA, with potential 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