Regulatory Affairs Manager jobs in Provo, UT

Quality Assurance and Regulatory Manager

Job Overview

Motivated, detail oriented, quality conscious and experienced professional. The Quality Assurance and

Regulatory Manager reports to the chief supply chain officer and it is responsible to manage and

maintain Bucked Up’s products and facilities in state of compliance with applicable regulations.

The position requires knowledge in the dietary Supplements quality and regulatory environments.

Beverage experience is a plus.

Objectives and Responsibilities

•  Assists and participates in the development and maintenance of Bucked Up’s Quality systems.
• Periodically conducts internal audits to verify compliance to current regulations and industry standards.
• Confirms quality procedures are properly carried out and documented per applicable standards.
• Authority for acceptance/rejection, including release of goods and associated functions.
•  Establish product specifications repository and revision control process.
•  Work with innovation team and primary suppliers to establish label revision control.
•  Authority to approve quality specifications in collaboration with beverage packaging consultant and primary supplement suppliers.
• Assists and participates in the qualification and management of Bucked Up’s suppliers of goods and services.
• Assists in establishing supplier quality requirements and rating system for critical vendors.
• Determine overall label and product spec compliance for Bucked Up’s brands and products.
• Helps the innovation department and collaborate with copackers in gathering and evaluating raw materials for new and existing projects and products.
• Assists and participates in customer complaints evaluation and reporting.
• Establish database and information gathering SOP on damaged inventory, perform root-cause and corrective action analysis, and reporting on trends.
• Performs root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvement opportunities.
•  Evaluates and develops CAPAS when non-conformances are identified at Bucked Up’s as well as at contract manufacturing/packaging facilities.
• Responsible for good documentation practices.
• Educates and instructs Bucked Up’s team members in regards to current cGMP and all applicable current regulations.
• Assists in the development of special projects and works in conjunction with other departments as needed.
• Provides support during customer and agency audits.
• Additional duties as needed.

Skills and Qualifications

• 2 years in a Regulatory/Quality role.
•  Detail oriented.
•  Excellent interpersonal/communication skills.
•  Experience in a Quality Assurance/Quality Control environment required.
• Bachelor’s degree in science preferred.
• Experience with Office (Word/Excel).
• Excellent written and verbal communication skills.
• Ability to interact efficiently with a multidisciplinary team.
• Ability to identify deficiencies and lead continuous improvement initiatives in cooperation with the other members of the quality team.
• Proficiency in the Dietary Supplements and Food Industries.