[Hiring] QA Label Coordinator @Emapta

Role Description

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

• 5-day work week
• Weekends off
• Work-from-home arrangement
• 20 vacation days in total
• Prepaid medicine
• Direct exposure to global 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

Qualifications

• 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

Requirements

• 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.