Tech Ops and Quality - Quality Control Technical Services Analyst IV

Analyst IV, Quality Control Technical Services

This position is hybrid role in Norton, MA with responsibility at both locations (Cambridge and Norton) as well as across sites contract organizations. The Quality Control Technical Services (QCTS) Analyst IV plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to active participation in stability studies, data trending, and investigations, this position will provide technical specification support and will assist in facilitating method transfers and implementation.

By ensuring these critical activities are executed with precision, the Analyst IV significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.

Key Responsibilities (including but not limited to):

• Provide robust support in the justification of technical specifications for raw materials, intermediates, and finished products, ensuring they meet all quality and compliance requirements.
• Facilitate the transfer and implementation of analytical methods from development to routine use within the QC laboratory, including method validation and training of laboratory personnel.
• Assist in the execution and documentation of stability studies, contributing to product shelf-life determinations and ensuring compliance with regulatory requirements.
• Engage in the collection, analysis, and trending of QC data to identify and address potential quality issues, using statistical tools to ensure continuous product quality monitoring.
• Support and sometimes lead investigations into analytical and product-related quality deviations, employing root cause analysis and implementing corrective and preventive actions (CAPAs) to mitigate risks and enhance quality.
• Review routine and non-routine QC testing, ensuring the reliability and accuracy of results according to policies, procedures, and regulations.
• Assist in preparing and reviewing technical documentation for regulatory submissions and audits, ensuring accuracy and compliance with global regulatory standards.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Actively represent Quality Control at cross-functional forums, including CMC meetings, ensuring QC perspectives and requirements are effectively communicated.
• Collaborate with other organizational functions, including CMC Development, Manufacturing, Manufacturing Technical Services, Supply Chain, Regulatory, and Quality Assurance to ensure alignment with overall business goals.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field; advanced degrees considered.
• Pharmaceutical/Biotech industry experience with 8-12 years in a GMP Quality Control function or equivalent, relevant industry experience
• Experience in technical specification development, method transfer, and/or analytical method implementation
• Proficient in data analysis and interpretation, with excellent attention to detail
• 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 Lab Ware LIMS, Excel, Word, and PowerPoint preferred