Oral Care Quality Liaison (INV) - 2307010216W

　　DESCRIPTION/RESPONSIBILITIES:DescriptionKenvue is recruiting for a Production Quality Liason, Oral Care Operations to be based out of Lititz, PA.

　　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 Responsibilties:* 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.

　　QualificationsWhat We Are Looking ForQualifications Required* B.S. or B.A. College Degree (Science or Technical Degree preferred)* 2-3 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

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

　　Role details:* Working hours must overlap with key partners to ensure efficient collaboration* Flexible/Partial work from home arrangements may be considered - must be on-site to conduct investigations and support production personnel

　　What's In It For You* Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!* Learning & Development Opportunities* Employee Resource Groups* This list could vary based on location/region

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