Sr. Specialist, R&D Quality

Kenvue•Fort Washington, PA

1d•Hybrid

About The Position

Kenvue is currently recruiting for a: Sr. Specialist, R&D Quality 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. 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 6 years experience required.
In pharmaceutical, consumer products, or FDA Regulated environment is preferred.
Proficiency in Microsoft Office applications is required.
This position is located in Fort Washington, PA and will require up to 10% travel on occasion to Summit, NJ and Lititz, PA.
Dependent upon the business needs with onsite product quality inspections, this position could be on a hybrid work schedule; 3x/week onsite, 2x/week remote

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
Experience in the overall product development process is preferred.
Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities 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
Excellent knowledge of procedures governing R&D GMP, Analytical/Micro, and GLP activities

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 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 both the Pilot Plant and with external manufacturers.
Provide oversight for R&D Analytical activities, including reviewing laboratory investigations, managing analytical method transfers, and validating these methods.
Provide quality oversight for all nutritional R&D activities.
Write and compile R&D quality agreements to ensure compliance and alignment with standards.