QA Label Coordinator

About the role

As a QA Label Coordinator you will ensure that all pharmaceutical labeling and packaging materials meet FDA regulations, cGMP standards, and internal quality criteria. You will work remotely, collaborating with global teams to support compliance and continuous improvement.

Key responsibilities

• Proofread and verify all printed and digital labeling assets, including cartons, labels, inserts, and promotional materials.
• Check compliance with the Code of Federal Regulations (CFR) and internal quality standards.
• Collaborate with graphic artists and Creative Services to resolve labeling questions.
• Review artwork and labeling jobs promptly according to proofing procedures.
• Maintain accurate documentation for label quality assurance processes.
• File National Drug Code (NDC) listings and manage Structured Product Labeling (SPL) submissions to the FDA.
• Support continuous‑improvement initiatives to enhance labeling quality and regulatory compliance.

Required profile

• Bachelor’s degree (preferred) and 1‑3 years of experience in quality assurance, labeling, or regulatory documentation.
• Strong command of English grammar, punctuation, and exceptional attention to detail.
• Excellent written and verbal communication skills.
• Ability to sit or stand for extended periods while performing proofreading tasks.
• Strong visual acuity for reviewing printed and digital proofs.

Required skills

• Microsoft Word
• Microsoft Excel
• Adobe Acrobat (preferred)
• Product Lifecycle Management (PLM) systems such as Agile (preferred)
• GlobalVision proofing software (preferred)
• Knowledge of FDA regulations and cGMP guidelines (preferred)
• Understanding of Structured Product Labeling (SPL) filing requirements (preferred)

What we offer

• Indefinite‑term contract with a 5‑day work week and weekends off
• Remote work arrangement
• 20 vacation days per year
• Prepaid medicine benefit
• Direct exposure to global pharmaceutical clients
• Career growth and upskilling through Emapta Academy courses
• Diverse, inclusive and supportive work environment