Production Quality Liaison

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Location:

Work Location:

What you will do

Supports Lititz and Network Quality Unit functions related to Investigation/CAPA and other GMP documents. This position provides daily direction, planning, and compliance focus for the Business Unit consistent with Supply Chain Goals while meeting the compliance goals of Quality Assurance.

Supports the activities of the site’s Investigation/CAPA program. Responsible for reviewing, approving and ensuring that INVs and CAPAs are completed, as stated in the standard operating procedures. Responsible for the administration, effectiveness and continuous improvement of the Business Unit's Investigation/CAPA system. Responsible for representing the Business Unit in CAPA Review Board for the site.

Ensures Investigation/CAPA Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (CGMP) regarding quality methods and manufacturing and packaging processes and procedures. Provides compliance perspective and expertise to ensure that the process consistently meets all internal and Regulatory Quality standards.

Are you interested in joining a team in a fast-paced environment where we are working to improve the lives of our customers and employees? Apply today!!

Key Responsibilities:

• Conduct Root Cause analysis of the following: Manufacturing Deviations, Nonconformances, Change Control, INV/CAPA, Quality
• Technical writing: Quality investigations, Root Cause analysis investigation o Corrections (SOPs, Wis, JAs) o Quality Alerts
• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Supports Investigation/CAPA process
• Develops and Submits CAPA/Action Items, SOPs, specifications, Protocols/Report, Maintenance forms, and Investigations for cGMP compliance when appropriate.
• Participates in internal and external audits
• Acts as an SME for Investigation/CAPA process
• Provides cGMP compliance guidance and delivers training/capability building to the Business Unit
• Ensures the Business Unit is in compliance with the CAPA procedure and processes.
• Collaborates with functional areas in the data analysis of the quality indicators for trends. Ensures that systematic situations, trends and key performance measures are escalated to management or CAPA Review Board and prioritized according to the processes and risks involved.
• Provides real-time compliance consulting and expertise to the site.
• Ensures appropriate focus on compliance goals and issues at Daily Business Unit meetings.
• Actively supports compliance improvement and training initiatives.
• Measure, track, trend and promote improvement of process metrics.
• Performs other functions as required.

What We Are Looking For

Required Qualifications

• B.S. or B.A. College Degree (Science or Technical Degree preferred)
• 3-5 years Pharmaceutical Industry Quality/FDA Regulated Experience required, with proven success in quality systems/compliance improvement preferred
• Active cGMP Interpretation and Application Experience
• Demonstrated leadership- possesses the ability to lead by influence
• Strong Organizational Skills
• Ability to coordinate and delegate tasks
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Demonstrated proficiency with Problem Solving/Investigation required

Desired Qualifications

• Process Mapping experience
• Statistical Analysis experience
• Ability to work a flexible schedule and accommodate investigation/CAPA activities across multiple shifts as needed

What’s in it for you

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.