Specialist, R&D Quality & Compliance

Kenvue•Lititz, PA

1d•Onsite

About The Position

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, click here. Role reports to: SENIOR MANAGER RD QUALITY AND COMPLIANCE Location: North America, United States, Pennsylvania, Lititz Work Location: Fully Onsite What you will do The Specialist R&D Quality & Compliance (R&D Q&C) is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient, and continuously improving to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP), and within Kenvue policies and Standard Operating Procedures. The Specialist is responsible for documentation quality review/approval, audit inspection support, documentation maintenance and archival, onsite quality inspections of product, and participating on internal assessments. Assist in compiling documentation to release R&D studies. Provide guidance on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners.

Requirements

Minimum of Bachelor’s Degree in Chemistry, Biology, Engineering, or related science is required.
A minimum of 3 years of experience is required; experience in a pharmaceutical, consumer products, or FDA‑regulated environment is preferred.
Proficiency in Microsoft Office applications is required.
This position is located in Lititz, PA and will require up to 10% travel on occasion to Summit, NJ and Fort Washington, PA

Nice To Haves

Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various product classification types (cosmetic, OTC/OTC Monograph and Medical Devices) is preferred.
Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities is preferred.
Experience in the overall product development process is preferred.
Problem solver (proactive in providing and executing solutions)
Highly committed to Quality and being Detail Oriented is required
Ability to Independently plan, organize, co-ordinate, manage, and execute assigned tasks
Ability to work collaboratively in team environments
Written and oral proficiency in the English language is preferred
Strong communicator with excellent interpersonal skills and diplomacy
Good conflict handling/negotiation skills

Responsibilities

Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, Labeling, Stability, Raw Material) and related documents, including Lab, Pilot, and Trial scale batches.
Responsible for the onsite quality inspection of supplies for R&D studies.
Participate in R&D project teams as the Quality representative.
Provide Quality guidance on GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, and Annex 13), including training of R&D personnel.
The Specialist is responsible for the GMP documentation maintenance, storage, and archival process, including the daily activities supporting this process.
Participate in the development and implementation of GMP and Quality & Compliance processes and procedures.
Participate in and perform internal assessments of R&D GMP processes and areas.
Participate in inspection readiness activities.
Assist in the compilation and presentation of R&D Quality Metrics during relevant meetings and forums.
Support quality assurance processes for R&D manufacturing activities in the Pilot Plant.