Dexian · 2 hours ago
GMP Documentation Specialist
Erlanger, KY
Contract
Onsite
Mid Level
$30/hr - $35/hr
3+ years expDexian is a leading provider of staffing, IT, and workforce solutions. They are seeking a GMP Documentation Specialist responsible for managing regulatory documentation, coordinating with global customers, and ensuring compliance with various regulatory standards.
ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency
Hiring Manager
Prathamesh Waghmode
Responsibilities
Data maintenance: vendor communication, interpretation of vendor documents and creation and maintenance of technical data in the company database for purchased ingredients and finished flavors and food bases
Documentation: coordinates across functions and is responsible for the creation, issuance and updating of product documentation, which includes specifications, ingredient and allergen statements, nutritional information, GMO-status reviews, organic compliance, Kosher, Halal, country compliance, country of origin, SDS and other Regulatory documentation provided to customers and technical personnel as needed
Assesses pending formula revisions /communicates any change notices required
Assists in managing, reviewing, and revising Regulatory ISO work instructions; reviewing and applying Regulatory or client policies & practices; and maintaining local Regulatory Intranet page, customers purchasing specifications
Acts as an information resource and represents the regulatory viewpoint for both internal and external customers. This includes the provision of education and guidance to R&D and commercial teams on various regulatory topics
Communicates with external governing agencies, third party certifiers and trade associations; participates in internal or external audits as required
Performs other duties and special assignments as required. Willing to travel to corporate offices and industry functions when applicable
Qualification
Required
Technical understanding of regulatory documentation and ability to conduct detailed research & interpretation of rules and guidance applicable to the Companys product portfolio and ingredients used therein
Excellent organizational, customer service, and communication skills for coordinating regulatory needs with global customers and colleagues
Communication skills that help to relate regulatory topics to non-regulatory audiences (Sales, R&D)
Ability to set priorities and work under pressure to meet deadlines with minimal supervision
Attention to detail to minimize internal and external complaints
Data maintenance: vendor communication, interpretation of vendor documents and creation and maintenance of technical data in the company database for purchased ingredients and finished flavors and food bases
Documentation: coordinates across functions and is responsible for the creation, issuance and updating of product documentation, which includes specifications, ingredient and allergen statements, nutritional information, GMO-status reviews, organic compliance, Kosher, Halal, country compliance, country of origin, SDS and other Regulatory documentation provided to customers and technical personnel as needed
Assesses pending formula revisions /communicates any change notices required
Assists in managing, reviewing, and revising Regulatory ISO work instructions; reviewing and applying Regulatory or client policies & practices; and maintaining local Regulatory Intranet page, customers purchasing specifications
Acts as an information resource and represents the regulatory viewpoint for both internal and external customers. This includes the provision of education and guidance to R&D and commercial teams on various regulatory topics
Communicates with external governing agencies, third party certifiers and trade associations; participates in internal or external audits as required
Performs other duties and special assignments as required. Willing to travel to corporate offices and industry functions when applicable
College Degree in Scientific Field
Minimum 3-5 years work experience, preferably in regulatory compliance for the food/beverage/flavor, or cosmetic/oral-care industries
Strong, independent analytical and problem-solving skills
Strong computer skills: proficient in MS Office packages; trainable in ERP system and other internal software
Proven interpersonal skills including ability to work well in a team environment, as well as excellent written and oral communication skills
Planning/organizing: ability to focus on priorities and work under pressure to meet multiple deadlines with minimal supervision
Solid attention to detail
Preferred
Proficiency in FDA and Canadian regulations, as well as familiarity with EU food and flavor regulations
USDA labeling experience preferable
Laboratory analytical skill is a plus
Project management experience would be beneficial
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
1001-5000 employees
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageLeadership Team
Mahfuz Ahmed
Chairman of the Board
Vikram Motiani
Managing Director
Recent News
2025-11-19
Company data provided by crunchbase