What are the responsibilities and job description for the Quality Control Analyst - II position at Alinco IT?
Job Overview
- Perform routine and non-routine analytical and/or microbiological assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
- Support a continuous operational schedule by supporting weekend laboratory operations (Analytical, Microbiology, Raw Materials).
- 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 are reviewed timely; qualify as a data reviewer to ensure timely and efficient data availability.
- Perform role-specific operational assignments (e.g., raw material processes including SAP transactions, environmental monitoring, in-process 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 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 testing techniques, TOQ operations, and regulatory compliance.
- May assist in preparing technical documentation for regulatory submissions by performing data verification, ensuring accuracy and compliance with regulatory standards.
- Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
- Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
- Collaborate with other organizational functions including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance to ensure alignment with overall business goals.
Job Types: Full-time, Contract
Pay: From $43.00 per hour
Schedule:
- 10 hour shift
- 8 hour shift
- Day shift
- Monday to Friday
Work Location: In person
Salary : $43
