Job Description
Title: Analyst II, Quality Control Operations
Location: Norton, MA 02766 (Fully onsite)
Duration: 12 months
Overview
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 .
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):
Qualifications
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Location: Norton, MA 02766 (Fully onsite)
Duration: 12 months
Overview
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 .
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 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 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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Numbers & Facts
| Location | Norton, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $43.54–$46.50 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!
Skills
- Analysis Skillsunmatched
- Assaysunmatched
- Biochemistryunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Contract Analysisunmatched
- 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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