Quality Control Analyst 2
Norton, OH - USA
Job Summary
Location: Norton MA 02766 (Fully onsite)
Duration: 12 months
Overview
The Quality Control Technical Operations (QCO) Analyst II plays a role in supporting the departments efforts to maintain the highest standards of quality and compliance from development through to 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 departments 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
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We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.
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Required Experience:
IC