Contract Senior QC Technical Services Analyst - GMP & Data

Proclinical; Norton (VA); Presencial; USD 69.000 - 83.000; Jornada completa

Descripción de la vacante

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

Responsibilities include developing technical specifications, validating analytical methods, performing CAPAs, and preparing regulatory documentation.

Formación

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

Responsabilidades

• Support the development and justification of technical specifications for raw materials, intermediates, and finished products.
• Facilitate the 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, such as CMC meetings, 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

Data analysis

CAPA investigations

Investigations

Problem solving

Communication

Teamwork

Herramientas

LabWare LIMS

Excel

Word

PowerPoint

Descripción del empleo

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

Responsibilities include developing technical specifications, validating analytical methods, performing CAPAs, and preparing regulatory documentation.