Quality Specialist - Compliance

Perrigo•Eau Claire, WI

1d•Onsite

About The Position

The Quality Specialist is responsible for the improvement and management of quality systems supporting consumer preference and trust. This position will oversee the management of the Document Control Program. This position will work autonomously under the supervision of the Quality Compliance Supervisor. The scope of the role includes owning knowledge transfer and continuous improvement in methodology through updated methods as technology is available, and the integration of point-of-use documents utilizing the best approach for operator use. The Quality Specialist will ensure the Document Control program complies with requirements from all applicable regulatory bodies and support the facility during internal and external audits and assessments including but not limited to: FDA, USDA, WDA, Kosher, Halal, ISO and other requirements. This role maintains the conformance, sustainability, and improvement of the Document Control program, identifying and implementing technological solutions as available. The specialist will support the facility in creating, revising, issuing, controlling, and maintaining controlled documents that relate to the manufacture of products produced at the facility. This position also oversees any other controlled documents required by the quality, food safety, safety, and environmental management teams. The role facilitates the document review process to ensure reviews are completed accurately and in a timely manner and prepares and maintains document templates to ensure compliance with company formatting requirements. This position will coach users and conduct training related to Document Control procedures/processes as needed. In terms of People and Know-How, the specialist will develop, coach, and train users to ensure highly effective and efficient quality systems, promote effective collaboration and document control practices throughout the facility, and identify areas for improvement related to document control.

Requirements

Bachelor’s Degree or equivalent (preferred microbiology, chemistry, or food science)
2 or more years of quality related experience
Experience in regulated food manufacturing environment with exposure to 21 CFR 106, 21 CFR 107, 21 CFR 117, Lean manufacturing philosophy, and FSSC 22000/SQF regulations is preferred, but not required.
Ability to work independently and translate technical/quality/compliance theory into practical application
Proficiency with PCs and software such as Access; Excel; Word; PowerPoint
Strong organizational skills and detail oriented.

Responsibilities

Oversee the management of the Document Control Program.
Ensure Document Control program complies with requirements from all applicable regulatory bodies.
Support facility during internal and external audits and assessments.
Maintain the conformance, sustainability, and improvement of Document Control program.
Identifying and implementing technological solutions as available.
Support the Facility in creating, revising, issuing, controlling, and maintaining controlled documents.
Oversee any other controlled documents required by the quality, food safety, safety, and environmental management teams.
Facilitate document review process to ensure reviews are completed accurately and in a timely manner.
Prepare and maintain document templates to ensure compliance to company formatting requirements.
Coach users and conduct training related to Document Control procedures/processes as needed.
Develop, coach, and train the users to ensure highly effective and efficient quality systems.
Promote effective collaboration and document control practices throughout the facility.
Identifies areas for improvement related to document control.