Quality Control Technical Services Analyst IV

Uncover Insights to Revolutionize Medicine

Join a team dedicated to driving breakthroughs in patient care by supporting quality and compliance efforts from development through commercialization. This role focuses on maintaining high standards of quality and regulatory compliance while ensuring laboratory operations run efficiently.

Primary Responsibilities

• 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.

Skills and Requirements

• Experience in a GMP QC environment 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.

Compensation

$50 to $60 per hour.