Quality Control Technical Services Analyst IV

Proclinical; Norton (MA); Vor Ort; GBP 51.000 - 62.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP QC experience

Technical specification development

Method transfer

Analytical data interpretation

CAPA investigations

Multi-tasking

Teamwork & communication

Tools

LabWare LIMS

Excel

Word

PowerPoint

Jobbeschreibung

Quality Control Technical Services Analyst IV - Contract - Norton, MA

Looking to uncover insights that could revolutionize the future of medicine and drive breakthroughs in patient care?

Proclinical is seeking a Quality Control Technical Services Analyst to support quality and compliance efforts from development through commercialization.

Primary Responsibilities

This role involves contributing to stability studies, data analysis, investigations, and method transfers while ensuring laboratory operations run efficiently. The position requires collaboration across multiple teams and locations, with a focus on maintaining high standards of quality and regulatory compliance.

Skills & Requirements

• Experience in a 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 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.

The Analyst's responsibilities will be

• 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.

Compensation

• $50 to $60 per hour.