Specialist, R&D Quality & Compliance

Description

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.

Key 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.

The Specialist will work with these groups related to GMP issues, project plans, due dates, and problem identification and resolution along with assisting in compiling documentation to release R&D studies.


* 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 process...