Operational Quality Technician / Team Lead

Job Description

WHO WE ARE

Caligor Coghlan (“CalCog”) is dedicated to optimizing the clinical supply chain, helping to speed the delivery of life-changing therapeutic innovations to patients worldwide. We feel good about the work that we do – for more than 29 years, CalCog has been dedicated to supporting the R&D supply chain.

As a global company, our services include clinical packaging design, clinical packaging and labelling, global storage and distribution, commercial and ancillary product procurement, and medical product supply management to support post-trial and early access programs.

We pride ourselves in making it our business to find a better way to deliver for our clients and the patients they serve. Our dedicated people care - about their work, their team, and the results we strive to deliver every day. If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.

POSITION SUMMARY

The Operational Quality Technician / Team Lead (Labeling) is responsible for ensuring that products meet established quality standards and specifications throughout the pre-production and production process. This role performs inspections, tests, and measurements, identifies deviations or defects, and collaborates with pre-production and production teams to maintain high-quality standards. This role involves leading packaging and labeling runs at CalCog’s Bastrop facility ensuring operations are performed in accordance with current Good Manufacturing Practices (cGMP), safety standards, and CalCog procedures.

ORGANIZATIONAL POSITION

This role reports to the Director of Quality with a dotted line into the Operations Manager for daily scheduling and resource coordination.

RESPONSIBILITIES

Quality & Inspection Duties :

• Perform in-process, incoming, and final inspections of materials, packaging, and finished products according to quality procedures and specifications.
• Identify non-conforming materials or products and assist in root cause analysis and corrective action implementation.
• Monitor and verify compliance with operational procedures, work instructions, and product standards.
• Support training of production personnel in quality control procedures and good manufacturing practices (cGMP).
• Ensure Operational SOPs are followed to meet Quality Standards.
• Maintain documentation in alignment with Quality Management System (QMS) and cGMP.

Team Lead – Labeling Responsibilities :

General :

QUALIFICATIONS, EXPERIENCE AND SKILLS