Contract QC Technical Services Analyst IV – Data-Driven

Proclinical; Norton (MA); Presencial; GBP 51.000 - 62.000; Jornada completa

Descripción de la vacante

Proclinical is seeking a Quality Control Technical Services Analyst IV (Contract) to support quality and compliance from development through commercialization. The role focuses on stability studies, data analysis, investigations, and method transfers, with collaboration across multiple teams and locations to maintain high standards of regulatory compliance.

The analyst will develop technical specifications, transfer analytical methods, and document regulatory submissions while supporting

Formación

• Experience in GMP QC within pharma or biotech.
• Knowledge of technical specification development, method transfer, and analytical method implementation.
• Strong data analysis and interpretation skills with attention to detail.
• Problem-solving abilities, including investigations and CAPA implementation.
• Excellent organizational skills and ability to manage multiple tasks independently.
• Effective communication and teamwork skills for collaborative environments.

Responsabilidades

• Support development and justification of technical specifications for raw materials, intermediates, and finished products.
• Facilitate transfer and implementation of analytical methods, including validation and training of laboratory personnel.
• Execute and document stability studies to determine product shelf life and ensure regulatory compliance.
• Analyze and trend QC data using statistical tools to monitor and address quality issues.
• Investigate analytical and product-related quality deviations, performing root cause analysis and implementing corrective actions (CAPAs).
• Review routine and non-routine QC testing to ensure accuracy and reliability of results.
• Prepare and review technical documentation for regulatory submissions and audits.
• Participate in continuous improvement initiatives to enhance QC processes and laboratory efficiency.
• Represent Quality Control in cross-functional forums to communicate QC perspectives and requirements.
• Collaborate with teams across CMC Development, Manufacturing, Technical Services, Supply Chain, Regulatory, and Quality Assurance to align with business goals.

Conocimientos

GMP QC experience

Technical specification development

Method transfer

Analytical data interpretation

CAPA investigations

Multi-tasking

Teamwork & communication

Herramientas

LabWare LIMS

Excel

Word

PowerPoint

Descripción del empleo

Proclinical is seeking a Quality Control Technical Services Analyst IV (Contract) to support quality and compliance from development through commercialization. The role focuses on stability studies, data analysis, investigations, and method transfers, with collaboration across multiple teams and locations to maintain high standards of regulatory compliance.

The analyst will develop technical specifications, transfer analytical methods, and document regulatory submissions while supporting