Our goal is to redefine IT staffing by embracing diversity and inclusion, connecting clients with exceptional and skilled professionals who bring innovative solutions while fostering an environment where every individual feels valued and empowered to thrive.
Labeling Coordinator
Type: Contract, W2 only
Duration: 12+ months
Location: Branchburg, NJ
Pay: up to $28.75/hr
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
A leading Global Biotech Company is seeking a precise and detail-oriented Labeling Coordinator with experience in the pharmaceutical or diagnostics industries and a strong understanding of FDA regulations. This role focuses on creating and updating labeling designs while adhering to strict Standard Operating Procedures (SOPs) and regulatory standards in a compliance-driven work environment. The ideal candidate will possess excellent attention to detail, ensuring documents are properly reviewed and quality-assured, with a proven ability to manage workflows, reviews, and approvals effectively.
Responsibilities:
- Develop, format, and revise product labels, IFUs, cartons, and related labeling components for diagnostic products.
- Ensure all design outputs align with corporate standards and meet all regulatory requirements for new product launches and product updates.
- Conduct careful reviews and quality assurance of design files, identifying and rectifying errors to ensure compliance before approval/submission.
- Collaborate with cross-functional teams, including regulatory, quality, and product management, to execute designs consistent with required specifications and approvals.
- Populate templates with accurate, detailed, and approved data to ensure proper standardization and consistency across all materials.
- Utilize corporate workflow systems to track progress, manage reviews, gather approvals, and maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Qualifications:
- Bachelor's degree in Graphic Design, Communication Design, or relevant field.
- 3+ years of experience in graphic design within pharmaceutical, diagnostics, or FDA-regulated industries.
- Comprehensive understanding of FDA labeling requirements, regulatory workflows, and compliance standards.
- Proficiency in design software, particularly Adobe Creative Suite (Illustrator, InDesign), and familiarity with workflow tools and project management systems.
- Superior attention to detail with demonstrated experience in quality assurance and compliance-focused document review.
- Strong organizational and time management skills, capable of managing strict deadlines.
- Ability to work in a highly regulated, process-oriented environment while maintaining professionalism and accuracy.
- Strong communication and collaboration skills.
- Proficiency with label creation software such as (EasyLabel, & Bartender).
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.