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Operational Quality Technician / Team Lead
Operational Quality Technician / Team LeadCaligor Coghlan • Bastrop, TX, United States
Operational Quality Technician / Team Lead

Operational Quality Technician / Team Lead

Caligor Coghlan • Bastrop, TX, United States
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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 :

  • Lead and oversee all packaging and labeling operations as the primary point of responsibility.
  • Compliantly and efficiently complete pre- and post-production batch records.
  • Effect pre- / post-production room inspection and charge-in drug and packaging supplies for production runs.
  • Ensure packaging and labeling operations adhere to all applicable regulations (i.e. cGMP and FDA).
  • Drive continuous improvement initiatives within the labeling process, focusing on accuracy, efficiency, and compliance.

    • General :

  • Participate in audits, inspections, and quality events (deviations, CAPAs, change controls).
  • Collaborate with cross-functional teams to improve product quality, process reliability, and operational efficiency.
  • Promote a positive, team-oriented work environment through active communication and support.
  • Other duties as assigned according to the changing needs of the business.

    • QUALIFICATIONS, EXPERIENCE AND SKILLS

  • High school or equivalent required, Bachelor’s degree in life sciences, pharmacy, or related field preferred.
  • 2+ years of QC experience or the equivalent combination of education and related work experience in a GxP regulated employment setting.
  • Knowledge of cGMP regulations (21 CFR Part 210 / 211), GDP, and applicable quality systems is a plus.
  • Experience using ERP or warehouse management systems.
  • Excellent attention to detail, organization, and problem-solving skills.
  • Ability to work independently while supporting a team-based environment.
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    Quality Technician • Bastrop, TX, United States