Quality Control Analyst

Integrated Resources, Inc ( IRI ); Norton (MA); Hybride; USD 110 000 - 140 000; Plein temps

Résumé du poste

Integrated Resources, Inc (IRI) is seeking a QC Analyst IV to support stability studies, data trending, investigations, and method transfers across Cambridge and Norton, MA, and client sites. Precision and regulatory compliance are essential as you collaborate with QA, CMC, Manufacturing, Regulatory, and Quality Assurance teams.

You will review QC testing, assist in regulatory submissions, and drive continuous QC process improvements while mentoring lab personnel in analytical methods and

Qualifications

• Bachelor-level science degree with GMP/QC exposure.
• Experience in technical specification development, method transfer, or analytics.
• Strong data analysis and investigative capabilities.

Responsabilités

• Support justification of technical specs for materials and finished products.
• Transfer analytical methods from development to QC use and train staff.
• Conduct and document stability studies and trend QC data.
• Lead investigations into deviations with CAPA implementation.
• Review routine and non-routine QC testing per policies and regs.
• Prepare technical docs for regulatory submissions and audits.
• Participate in cross-functional forums (CMC, Regulatory).

Connaissances

Data analysis

Attention to detail

Problem-solving

Communication

Teamwork

Organizational skills

Autonomy

Formation

Bachelor's degree in Chemistry, Biology, or Biochemistry

Outils

LabWare LIMS

Excel

Word

PowerPoint

Description du poste

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.

This position is hybrid role in Norton, MA with responsibility at both locations (Cambridge and Norton) as well as across client contract organizations.

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 LabWare LIMS, Excel, Word, and PowerPoint preferred