Kenvue is currently recruiting for:

Quality Systems Specialist

Who we are

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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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.

Role reports to: Quality Systems Manager

Location: Skillman, NJ (Kenvue's corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.)

Travel : 10%

Pay: $ 73,000 - 117,300

What you will do

The Quality Systems/Quality Control (QS/QC) Coordinator, as part of the Quality Systems role is responsible for supporting Change Control, Investigation, Corrective Actions and Preventative Actions (CAPA), Metrics, Training and Document Control.

The Quality Control role is responsible for providing product and stability testing expertise, to include microbiology, chemistry, and stability for OOS/MPS investigations, the QS/QC Coordinator will support the preparation, review, processing, approval, and closure of change controls, and will assist change control owners in the research and writing of change controls. The QS/QC Coordinator will initiate and author internal JJCI Quality Systems investigations and CAPAs, as needed. You will also be the primary Subject Matter Expert (SME) for the Training system as well as the Document Control Process (Tru). You will also provide oversight of all change controls, investigations, and CAPA within the EtQ system. You will drive results and are responsible for the administration, effectiveness and continuous improvement to ensure the viability of these processes. The QS/QC Coordinator will also serve as a Super User for the EtQ and Qlik systems and is responsible for local system administration. You will participate as a team member on both internal and external project teams interfacing primarily with Technical, Quality Assurance, Internal Operations and R&D groups, and supporting EMs with test result OOS or investigations related to microbiology, chemistry, stability issues. This role will also maintain the audit playbook and establish an audit readiness program to support the auditing process to include internal, JJRC and Regulatory audits. . This position will collect and monitor weekly, monthly, quarterly metrics as well as identifying trends, opportunities, and overall adherence to the Metric monitoring processes.

Key Responsibilities:

• Act as SME for Investigations, CAPA and Change Control systems

• Act as SME for metrics, training and document control

• Act as SME for laboratory and stability test results, as needed

• Review change controls, investigations, CAPAs for adherence to procedures

• Act as audit lead for internal, JJRC, and Regulatory Body audits

• Act as local ETQ Super User and Local Administrator

• Act as local Tru user

• Act as local ComplianceWire/Summit admin

• Report Investigation, CAPA and Change Control metrics

• Report training, document control metrics

• Develop robust metric reporting process • Special projects as required

What we are looking for

Required Qualifications

• A minimum of a Bachelor's Degree (BA/BS) is required.

• A focused degree in Chemistry, Microbiology, Biology, or Biological Sciences or Information Management is preferred. Experience:

• A minimum of 4 years of GMP Quality and Compliance experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Industry.

• Detailed working knowledge of cGMP requirements and current FDA enforcement issues.

• Experience in MS Word, Excel, and Power Point applications is required

• Strong experience in EtQ, Qlik, TRU, Compliance Wire, and Summit

• Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with senior levels of management to inform, drive change, and provide direct feedback

• Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.

• Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability required

Desired Qualifications

• Proven ability to lead and influence others within product teams with excellent communication and presentation skills

• Experience working with business partners in a global environment is preferred

• Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority

• Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution

What's in it for you

• Annual base salary for new hires in this position ranges from $73,000 to $117,300 This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

• Competitive Total Rewards Package*

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

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