Quality Control Analyst III

• B.S. in chemistry, biology, or biochemistry, or related scientific field;
• Pharmaceutical/Biotech industry experience with 6-10 years in a GMP Quality Control function or equivalent, relevant industry experience
• Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach is desirable
• Demonstrated technical writing skills, with preference for technical writing of investigations
• Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making
• Solid problem-solving skills and experience in conducting investigations and implementing CAPA
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

Key Responsibilities (including but not limited to)

1. 1Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
2. 2Maintain 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
3. 3Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
4. 4Ensure data are reviewed timely; qualify as a data reviewer to ensure timely and efficient data availability.
5. 5Perform role-specific operational assignments (e.g., analytical method transfer, release, stability, in-process testing, etc.).
6. 6Contribute 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
7. 7Adhere 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.
8. 8Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.
9. 9Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective Alnylam goals
10. 10Pursue ongoing training and development to deepen expertise in QC testing techniques, TOQ operations, and regulatory compliance.
11. 11May assist in preparing technical documentation for regulatory submissions by performing data verification, ensuring accuracy and compliance with regulatory standards.
12. 12Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
13. 13Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
14. 14Collaborate with other organizational functions including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance to ensure alignment with overall business goals.