17 ago
|
Emapta Global
|
Bogotá
17 ago
Emapta Global
Bogotá
Make Every Label a Mark of Pharmaceutical Quality and Compliance
Put your attention to detail behind the quality and compliance of global healthcare products. As a QA Label Coordinator , you'll support pharmaceutical quality assurance, FDA label compliance, regulatory documentation, packaging artwork review, NDC listings, SPL submissions, and cGMP requirements. Develop in-demand pharmaceutical labeling expertise while supporting international operations and advancing your career globally with Emapta.
Your Role at a Glance
- Employment type: Indefinite-term contract
- Shift: Day Shift, Weekends Off
- Work setup: Work From Home/Remote
Benefits Built Around Your Growth
- 5-day work week
- Weekends off
- Work-from-home arrangement
- 20 vacation days in total
- Prepaid medicine
- Direct exposure to integral clients
- Career growth opportunities
- Diverse, inclusive, and supportive work environment where every individual is respected, valued, and empowered to succeed
- Prime office locations in Bogotá and Medellín
- Unlimited upskilling through Emapta Academy courses (Want to know more? Visit https://emapta.com/training-calendar/ )
The Qualifications We Seek
- Bachelor's degree , preferred
- 1 to 3 years of relevant experience in quality assurance, labeling, regulatory documentation, or a related field
- Strong command of English grammar and punctuation, with exceptional attention to detail
- Excellent written and verbal communication skills
- Proficiency in Microsoft Word and Excel
- Working knowledge of Adobe Acrobat , preferred
- Familiarity with Product Lifecycle Management (PLM) systems , including Agile, preferred
- Knowledge of GlobalVision proofing software , preferred
- Knowledge of FDA regulations and current Good Manufacturing Practices (cGMP)
guidelines , preferred
- Knowledge of Structured Product Labeling (SPL) filing requirements , preferred
- Bilingual proficiency in English and Spanish , preferred
- Ability to sit or stand for extended periods while completing proofreading and computer-based tasks
- Strong visual acuity to review printed materials and digital proofs accurately
Your Daily Tasks
- Proof all company-printed materials, including Individual Folding Cartons (IFCs), labels, inserts, displays, mats, brochures, flyers, sales sheets, mockups, and Master Drug Facts.
- Verify all labeling materials for compliance with applicable Codes of Federal Regulations (CFRs) and internal quality standards.
- Collaborate with graphic artists and the Creative Services team to resolve labeling-related questions from internal teams and customers.
- Review artwork and labeling jobs promptly in accordance with established proofing procedures and regulatory requirements.
- Maintain accurate documentation and records for label quality assurance processes.
- File National Drug Code (NDC) listings and maintain Structured Product Labeling (SPL) submissions with the FDA.
- Support continuous improvement initiatives to strengthen labeling quality, regulatory compliance, and overall process effectiveness.
About the Client Our client is a leading pharmaceutical manufacturer, packager,
and distributor specializing in over-the-counter medicines and consumer healthcare products. They provide end-to-end capabilities spanning product development, manufacturing, packaging, quality assurance, regulatory compliance, and distribution.
With an extensive portfolio supporting major retailers and healthcare brands, they combine pharmaceutical expertise, advanced facilities, and rigorous quality standards to deliver accessible, reliable healthcare solutions while maintaining compliance with FDA regulations and current Good Manufacturing Practices (cGMP) throughout their operations.
Join the Top 1% Talent. A Better Career. A Better Life.
The world doesn't move forward because everyone is the same. It moves forward because people bring different perspectives, strengths, and ways of thinking. If you've been waiting for a workplace that sees your potential before anything else, this is your moment.
At Emapta Colombia, we believe great careers begin when people are recognized for what they can do-not defined by what others expect. That's why we're creating more opportunities for exceptional talent to thrive in an inclusive workplace where your skills are valued, your ambitions are supported, and your contributions make a lasting impact.
Since 2010, Emapta has helped transform global outsourcing through personalized solutions and seamless collaboration. Today, we're proud to support more than 1,200 clients worldwide with a community of over 12,000 talented professionals-all united by one belief: exceptional talent can come from anywhere.
Apply today and let your talent take the lead . The future of work needs people like you.
#EmaptaEra
📌 QA Label Coordinator (Bogotá)
🏢 Emapta Global
📍 Bogotá