Quality Specialist - Compliance

Perrigo; Eau Claire (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Perrigo in Eau Claire, WI is seeking a Quality Specialist - Compliance to drive improvement and management of quality systems, including the Document Control Program. The role works autonomously under the supervision of the Quality Systems and Compliance Manager.

You will own knowledge transfer, integrate documents for operator use, ensure compliance with regulatory bodies, and support audits. The position is the SME for OpenText and involves maintaining KPIs, document templates, and

Qualifications

• Bachelor’s degree or equivalent in a science field.
• 2+ years of quality experience in an FDA-regulated industry.
• Proficiency with Adobe Acrobat, Word, Excel, PowerPoint.

Responsibilities

• Oversee the Document Control Program and related KPIs.
• Support internal and external audits and assessments.
• Maintain conformance and improvement of the quality system.
• Coach OpenText users and promote best practices.

Skills

Quality systems

Document control

Regulatory compliance

Audits

CAPA management

OpenText

TrackWise

Training

Education

Bachelor’s degree in microbiology/chemistry/food science

Tools

OpenText

TrackWise

Articulate StoryLine

Adobe Acrobat

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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.

Description Overview

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.

Scope of the Role

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: OpenText. 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 OpenText 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.

Experience Required

• 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, PowerPoint

Experience Preferred

• 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 OpenText, TrackWise, and Articulate StoryLine software systems.

Other Skills

• 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 speaking in front of small to medium groups of people.

Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of 'America's Best Employers by State 2024'.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.

Nearest Major Market: Eau Claire

Equal Employment Opportunity/M/F/disability/protected veteran status.

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