Labeling Specialist

Company and Position Overview

United Exchange Corporation (UEC) is an established distributor of health and beauty care, OTC personal hygiene, and dry food consumer products. We also utilize a third-party manufacturer in Korea to make products of our own design.

UEC is seeking a skilled Labeling Specialist responsible for developing and implementing labels in support of new product development, product support, product registrations, quality-related labeling issues, business initiatives, and compliance activities. Coordinates with various functions on content development, global regulatory requirements, and operational tasks related to the design, development, implementation, review, and approval of all labeling for medical devices, drug products, food and cosmetics manufactured by company facilities and associated contract manufacturers.

Reports to: Head of Quality and Regulatory Compliance

Job classification: Full-time exempt

Location: Corporate headquarters at 5836 Corporate Ave., Ste. 200, Cypress, CA

Work location options: On site, hybrid, or remote work arrangements are all considered

Key Responsibilities

• Works cross-functionally to ensure client labeling objectives are met. Monitors progress; identifies risks and proposes solutions/improvements.
• Prepares materials and provides support for audits/inspections.
• Ensures that change control processes are followed to maintain accuracy of change during versioning of documents.
• Development and accuracy of the nutrition facts panel and ingredient declaration for a wide range of products
• Provides regulatory expertise to teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.
• Identifies areas of potential non-compliance and supports investigations as needed. Escalates issues pertaining to implementation of core labeling content, Master labels into product labeling to ensure compliance to regulations and standard processes. Identifies potential non-compliance and supports investigations as needed.
• Tracks compliance with established processes. Provides compliance data to department management, internal and external clients.
• Writes and tracks Corrective and Preventative Actions (CAPAs). Tracks and compiles department metrics.
• Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the core documents across product families and with all applicable best practices.
• Provides operational support through the management of change control of labeling documents, creation and maintenance of annual report labeling summary with Fine Printed Labeling (FPL), maintenance of current competitor lists and monitoring for updates impacting labeling, and support of labeling implementation tracking.
• Coordinates implementation of label changes with manufacturing plants. Manages inventory depletion with supply chain.

Desired Qualifications

• Bachelor's degree in a relevant field (e.g., regulatory affairs, life sciences, pharmaceutical, or a related discipline)
• Strong understanding of CFR 21 Part 101, Part 820, Part 210-211, Part 200-299, and Part 700-799 regulations
• 2+ years experience in regulatory affairs with medical devices and pharmaceuticals, OTC, and food products
• Familiarity with an ERP systems such as NetSuite or eQMS
• 3 - 5 years of labeling experience, preferably in OTC, cosmetics, medical devices, and/or food labeling
• Knowledge of GMP and regulated Quality Systems
• Ability to lead and implement cross-functional projects, develop project schedules, and communicate project status
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio)

Compensation: $65-75K

Benefits: Paid holidays, PTO, medical/dental/vision insurance, life insurance, 401(k) plan

About Us

United Exchange Corporation (UEC) is a minority-owned, privately held company established in 1993, and headquartered in Southern California. We pride ourselves on providing high-quality personal care and food products to retailers globally. Our efficient turnkey solutions, facilitated by two domestic distribution centers, have led to our products being showcased in over 100,000 retail stores across various channels, including mass, drug, grocery, convenience stores, and discount outlets.

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• How many years of labeling development and implementation experience do you have? What industries has this experience been gained?
• Do you have experience applying CFR 21 good manufacturing and packaging practices in either the food, pharmaceutical, or related industry?

Work Location: Hybrid remote in Cypress, CA