Analyst IV, Quality Control Technical Services

Join a cutting-edge pharmaceutical team where your precision and passion for quality analysis will help shape the future of life-saving medicines! Proclinical is seeking an Analyst IV for Quality Control Technical Services to support quality and compliance efforts from development through commercialization.

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 to identify and address potential quality issues using statistical tools.
• Investigate quality deviations, perform root cause analysis, and implement corrective and preventive 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, ensuring alignment with organizational goals.
• Collaborate with teams across CMC Development, Manufacturing, Supply Chain, Regulatory, and Quality Assurance.

Requirements

• Background in chemistry, biology, biochemistry, or a related scientific field.
• Experience in a GMP Quality Control function within the pharmaceutical or biotech industry.
• Proficiency in technical specification development, method transfer, and/or analytical method implementation.
• Strong data analysis skills with attention to detail.
• Problem-solving expertise, including conducting investigations and implementing CAPAs.
• Excellent organizational skills and ability to manage multiple tasks independently.
• Effective communication and teamwork abilities in a collaborative environment.
• Familiarity with LabWare LIMS, Excel, Word, and PowerPoint is preferred.

Pay

$55 to $68 per hour.