Job Description

Description:

Q.A & Regulatory Mgr.


Leavenworth, KS Regulatory Affairs


Come join our wonderful team culture, and be an integral part of our team!

Position Overview

The Quality Assurance & Regulatory Manager is responsible for reviewing ingredients and finished product documentation, setting up new products and ingredients, responding to customer documentation requests, and maintaining records of all incoming and outgoing documentation. This role works closely with the Director of Regulatory Affairs, Raw Ingredient Specialist, R&D Team, Quality Control Management, and other internal staff to develop and provide accurate technical documentation and information.

Primary responsibilities include, but not limited to:

Documentation and Compliance:

Complete customer requests for extensive technical documentation regarding both products and the facility. Create Certificates of Analysis (COAs), verify laboratory results, QA testing data, and release finished products for all outgoing finished products. Maintain accurate records and ensure proper record keeping and retention. Assist in the monitoring and development of finished product technical documentation, labels, and Certificates of Analysis for accuracy and compliance. Assist in the review of CII products for compliance with customer specifications/requirements, existing certifications, and regulatory standards. Assist CII in product development by reviewing new products for compliance and communicating any issues with the appropriate staff.

Ingredient and Supplier Management:

Evaluate new and existing ingredients thoroughly for compliance with company systems. Assist in the collection of relevant paperwork for each ingredient and maintain ingredient paperwork files for staff reference to ensure up-to-date data is available. Assist in the upkeep of databases of required information for ingredients and suppliers and communicate as needed with Procurement, Production, and R&D. Assist in the upkeep of supplier and ingredient documentation repositories. Keep accurate records of all raw materials and Kosher listings for all products produced.

Regulatory and Quality Assurance:

Assist in the design of standards and systems as they relate to quality, regulatory issues, or other items as needed. Assist in evaluating information to determine compliance with standards (e.g., new equipment, new certifications, new products). Perform documented compliance inspections as part of the facility compliance inspection team. Ensure all required compliance inspections are completed and that corrective actions are completed appropriately. Assist in oversight of the raw material testing and management systems. Assist with documented compliance inspections and develop solutions for any non-conformances found. Fills in for the Director of Regulatory Affairs as needed.

Communication:

Communicate courteously and professionally with customers, certifiers, internal staff, and regulatory agencies during review and discussions regarding technical product documentation, facility inspections, and/or certifications. Effectively communicate with plant personnel, frontline supervisors, and operating managers. Attend Regulatory and Management Team meetings as needed.

Other responsibilities as needed.

Benefits:

Paid Time Off Holiday Schedule Medical Dental Vision Life Insurance 401k Retirement Plan

Requirements:

BS in a related field required, and a strong food quality assurance and process knowledge.

Minimum 4 years relevant work experience in QA in a Food Manufacturing preferred. Certification: PCQI certified or willing to complete the Preventive Control Qualified. Individual course within 90 days. Excellent verbal and written communication skills and critical attention to detail. Ability to work well under pressure in a fast-paced environment and handle multiple tasks. Capable of prioritizing and planning work activities. Demonstrated accuracy and thoroughness with the ability to improve and promote quality. Ability to analyze information and evaluate results to choose the best solution and solve problems. Must be proficient in MS Excel and Outlook, with working knowledge of MS Word and PowerPoint

Working Environment and Physical Demands

Indoors temperature-controlled environment-office, laboratory, manufacturing facility; the use of hearing protection may be required at times, along with other personal protective equipment as necessary. Position requires the ability to sit, stand, walk, climb, manual dexterity, ability to see details at close range and to differentiate colors, ability to listen and to understand spoken words and phrases, ability to communicate information verbally, ability to read and understand ideas presented in writing, ability to communicate information and ideas in writing so that others will understand. Must meet the physical abilities level of Two (2) as defined by the US Department of Labor.