Specialist, R&D Quality & Compliance

Mcneil Ab; États-Unis; Hybride; USD 82 000 - 116 000; Plein temps

Avantages offerts par ce poste

Competitive Benefit Package

Paid Company Holidays

Volunteer Time & More

Résumé du poste

Kenvue is seeking a Specialist, R&D Quality & Compliance to administer integrated quality systems and ensure R&D functions comply with cGMP and company procedures. Responsibilities include documentation review, audits, archival activities, and regulatory guidance.

The role reports to Sr Mngr RD Quality & Compliance and is based in Summit, NJ with a hybrid work location. Requires 2–4 years in regulated environments and strong MS Office skills.

Qualifications

• Bachelor's degree in a relevant field or equivalent experience.
• 2-4 years in pharmaceutical, cosmetics, consumer products, or FDA-regulated environment.
• Experience working effectively in a team-based environment.
• Strong organizational skills.
• Strong communication/interpersonal and facilitation skills (verbal, written and presentation).
• Expertise in Handling Multiple Priorities.
• Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint).

Responsabilités

• Review and approve GMP documentation and batch records, including laboratory batches with process controls.
• Conduct quality inspections of supplies for R&D studies.
• Serve as Quality representative on R&D project teams.
• Provide GMP regulatory guidance and training.
• Maintain GMP documentation, storage and archival processes.
• Participate in GMP/QC procedure development, revision, and implementation, and support related process improvements.
• Perform internal assessments and support inspection readiness.
• Collect, compile, and report North America R&D Quality metrics across Kenvue sites (monthly & semiannual).
• Support internal and GRC audit preparation and execution; including coordinating and gathering documentation for pre-audit requests.
• Manage non-marketed product quality complaints in accordance with applicable procedures.
• Assist in compiling documentation for R&D study release and inspection readiness activities.
• Provide additional training and procedural guidance to R&D personnel on Quality processes & GMP documentation.
• Identify and escalation quality and compliance gaps with assigned areas of responsibility.

Connaissances

Teamwork

Communication

Organizational skills

Prioritization

Microsoft Office

Formation

Bachelor's degree in a relevant field

Outils

Microsoft Office

Description du poste

Kenvue is currently recruiting for a:

Specialist, R&D Quality & Compliance

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 , .

Role reports to:

Sr Mngr RD Quality & Compliance

Location:

North America, United States, New Jersey, Summit

Work Location:

Hybrid

What you will do

The Specialist, R&D Quality & Compliance (R&D Q&C) is responsible for administering integrated and comprehensive quality systems and controls to ensure R&D functions operate in compliance with sound scientific practices, cGMP requirements, and company procedures. Responsibilities include documentation review and approval, audits, inspections, archival activities, internal assessments, support of R&D study releases, and regulatory guidance.

Key Responsibilities

• Review and approve GMP documentation and batch records, including laboratory batches with process controls.
• Conduct quality inspections of supplies for R&D studies.
• Serve as Quality representative on R&D project teams.
• Provide GMP regulatory guidance and training.
• Maintain GMP documentation, storage and archival processes.
• Participate in GMP/Q&C procedure development, revision, and implementation, and support related process improvements.
• Perform internal assessments and support inspection readiness.
• Collect, compile, and report North America R&D Quality metrics across Kenvue sites (monthly & semiannual).
• Support internal and GRC audit preparation and execution; including coordinating and gathering documentation for pre-audit requests.
• Manage non-marketed product quality complaints in accordance with applicable procedures.
• Assist in compiling documentation for R&D study release and inspection readiness activities.
• Provide additional training and procedural guidance to R&D personnel on Quality processes & GMP documentation.
• Identify and escalation quality and compliance gaps with assigned areas of responsibility.

What we are looking for

Required Qualifications

• Bachelor's degree in a relevant field or equivalent experience.
• Requires 2-4 Years in pharmaceutical, cosmetics, consumer products, or FDA-regulated environment.
• Experience with working effectively in a team-based environment.
• Strong Organizational Skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Expertise in Handling Multiple Priorities
• Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint)

Desired Qualifications

• Developing Product development process experience; knowledge of cGMP/cGLP requirements for cosmetic, OTC, and medical device products.

What's in it for you

• Annual base salary for new hires in this position ranges:

$82,025.00 - $115,800.00

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

Learning & Development Opportunities

• Kenvuer Impact Networks

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 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.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.