Quality Control Technical Services Analyst IV

Job Description

Job Summary:

• 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 .

Duties & Responsibilities:

• 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.

Required 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.