Quality Specialist - Compliance

Perrigo Quality Specialist - Compliance

Location:

Eau Claire, WI, US, 54703

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone
, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more.
We Are Perrigo
. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

The Quality Specialist is responsible for 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 Systems and Compliance Manager.

Own knowledge transfer and continuous improvement in methodology, through updated methods, as technology is available. Integration of point of use documents utilizing the best approach for operator use.

Quality Guardianship:
Ensure Document Control program complies with requirements from all applicable regulatory and certification bodies. Support facility during internal and external audits and assessments. This position will be the SME of the Document Control Management System:
Open Text. Maintains all KPIs related to Document Control and develop KPIs for continuous improvement.

Quality System:
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 that relate to the manufacture of products produced at the facility. Facilitate document review process to ensure reviews are completed accurately and in a timely manner. Complete controlled document audits of the production environment.

Prepare and maintain document templates to ensure compliance to company formatting requirements. Will serve as a back-up for other foundational Quality Systems: CAPA Management, Change Control, and Consumer Complaints.

People and Know-How:
Develop, coach, and train the Open Text 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.

• Bachelor's Degree or equivalent (preferred microbiology, chemistry, or food science)
• 2 or more years of quality related experience in an FDA regulated industry
• Proficiency with software systems, such as:
  Adobe Acrobat, Word, Excel, Power Point

• Experience in food manufacturing environment with exposure to 21 CFR 106, 21 CFR 107, 21 CFR 117, Lean manufacturing philosophy, and SQF regulations.
• Proficiency with Open Text, Track Wise, and Articulate Story Line software systems.

• Ability to work independently and translate technical/quality/compliance theory into practical application
• Strong organizational skills and detail oriented
• Ability to work with different people and departments
• Ability to meet shifting demands and priorities
• Knowledge of Internal/External Audits
• Knowledge of CAPA Management
• Must be able to stand/move for long periods of time when on the production floor and be willing to work in a 120°F+ environment (with breaks)
• Comfortability…