Regulatory Documentation Specialist

Position Summary :

Supports Regulatory & R&D department activities (development of new products, line extensions, evaluation of product improvements and cost reductions) by collecting and entering technical information into various product documentation and product management systems and/or programs. Collaborates with cross functional teams to ensure accuracy and compliance of product documentation across each system.


Essential Duties and Requirements include the following. Other duties may be assigned.

• Maintains the product documentation systems by collecting and entering technical and manufacturing information for raw ingredients and packaging materials, product formulation, and finished products.
• Enters technical information and data into the ERP system to support Manufacturing, Procurement, Sales, Quality Assurance, and Warehousing, as required.
• Coordinates the Product Manual review and setup process by implementing, tracking, and documenting cross-functional group reviews.
• Coordinates the Packaging Design Approval process by implementing, tracking and documenting cross-functional group reviews.
• Creates label templates and labels and coordinates the label approval process by implementing, tracking, and documenting cross-functional group reviews.
• Coordinates the documentation change processes for raw ingredients, packaging materials, product formulas and finished products.
• Responsible for assigning product numbers by completing Product Numbering Requests and notifying stakeholders upon completion.
• Collaborates on product development projects and provides project status updates to key stakeholders and Management.
• Contributes to cross-functional company initiative involving software enhancements and system upgrades by providing subject-matter insight, participates in testing activities, and supports implementation.
• Maintains the Documentation Specialist standard operating procedure manuals (practices, processes, and forms)
• Partners with Master Data team to monitor and maintain Master Data requests including item location setup, version control updates, and product deactivation requests.
• Creates code date templates for product packaging in compliance with regulatory, quality assurance, and for traceability purposes along with code date formats to align for product documentation.
• Responsible for promoting food safety and employee safety throughout the organization.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Skills

• Highly skilled with database, word processing, spreadsheet, and presentation software systems.
• Excellent data entry and keyboarding skills
• Highly organized and detail oriented
• Able to read, write and verbally communicate in English
• Able to complete assigned tasks with minimal direct supervision.
• Capable of prioritizing tasks to maximize team support
• Able to function in a fast-paced environment.
• Able to interact with all levels of the organization.
• Strong ability to maintain confidentiality.
• Able to work on deadlines to meet goals and adapt to schedule changes
• High level of personal, work and professional ethics.

Education and/or Experience

High school diploma or equivalent is required. Two year technical degree in applied sciences is preferred. Prior experience in a food manufacturing environment is desired, especially in Quality Control/Assurance or R&D.

Physical Ability

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms.

Position requires the occasional lifting of objects that may weigh as much as 50 lbs.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.