Job Title: Analyst II, Quality Control Operations Location: Norton, MA Duration: 12 months Pay Range: $40 - $44/hr. on w2
Note: This position is onsite and will be primarily located in Norton, MA. There may occasional responsibilities at a secondary location in Cambridge, MA.
Job Description:
The Quality Control Technical Operations (QCO) Analyst II plays a role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization.
In 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.
Key Responsibilities:
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 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 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.
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.
Education:
B.S. in chemistry, biology, or biochemistry, or related scientific field; Associate 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.
Numbers & Facts
Location
Norton, MA
Salary
$40–$44 Per Hour
Skills
Analysis Skillsunmatched
Assaysunmatched
Biochemistryunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Chemistryunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Detail Orientedunmatched
Document Managementunmatched
Environmental Monitoringunmatched
Equipment Maintenance/Repairunmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
ICH Regulationsunmatched
Industry Standardsunmatched
Laboratory Equipmentunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Operationsunmatched
Manufacturing Managementunmatched
Materials Managementunmatched
Materials Testingunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Operational Supportunmatched
Product Testingunmatched
Quality Assuranceunmatched
Quality Assurance Methodologyunmatched
Quality Controlunmatched
Quality Control Methodologyunmatched
Quality Metricsunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Submissionsunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
Technical Operationsunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Time Managementunmatched
Training/Teachingunmatched
Trend Analysisunmatched
Validation Testingunmatched
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