Tech Ops and Quality - Quality Control Analyst I

Overview The Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization. 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.

Title: Quality Control Operations Analyst I
Duration: 12 months
Location: Norton MA

• This position is onsite and will be primarily located in Norton, MA.
• There may occasional responsibilities at a secondary location in Cambridge,MA.

Overview

• The Analyst I in Quality Control Operations will play a critical role in executing assays, generating accurate and reliable data, and supporting the general operations of the laboratory to ensure the quality and compliance of our products from development through to commercialization.

Key Responsibilities:

• Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies under supervision, 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
• Accurately record experimental data and observations in compliance with GxP standards. Participate in the review of data commensurate with experience.
• 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 analytical techniques and regulatory compliance.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• 0 to 2 years of experience in a GMP/GLP regulated laboratory environment, with exposure to pharmaceutical or biotechnology industries preferred
• Understanding of analytical techniques and their application in raw materials, in-process testing, release, and stability studies is preferred
• Strong documentation skills and attention to detail, with an unwavering commitment to quality and compliance
• Basic awareness of regulatory guidelines relevant to pharmaceutical QC (GMP, GLP, ICH) is desirable
• Effective communication and teamwork skills, with the ability to work collaboratively across functions
• Capable of working under supervision and following detailed instructions

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We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

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