Specification Lead

Description

Kenvue is currently recruiting for:

Specification Lead

This position reports to Senior Manager Make Quality and is based at Fort Washington, PA

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.

For more information, click here .

Role reports to: Senior Manager Make Quality

Location: Fort Washington, PA

Travel %: 10

What you will do

The Specification Lead will work with cross-functional areas to ensure that the ICH guidelines, GMP, FDA guidance, Pharmacopeia, Industry standards, standard operating procedures (SOPs) are followed/ implemented.

Key Responsibilities

• Maintain the lifecycle of the finished products specifications/test methods and raw material specifications/test methods.

• Partner with R&D/ Procurement/ Change Control/EMQA and the Internal Manufacturing Sites to increase efficiency of finished products specifications /test methods and raw materials specifications/ test methods process.

• Lead meetings regularly with R&D, Regulatory Affairs, PSJ Primary members to discuss the projects strategies for the FDA submissions

• Simplify processes, requirements and procedural instructions/Review PSJ and specifications/ test methods SOPs to minimize redundance.

• Approve documentation of commercial raw material and finished products specifications and test methods as the final QA approver.

• Provide support for the raw material and finished products specifications APR contributions for the Internal Manufacturing and External Manufacturing sites.

• Lead the Product Specification Justification (PSJ) process and objectives

• Attend the US Self Care Compendium forum for specifications and test methods compendium change implementation.

• Identify the specifications/ test methods implementation strategies to meet the requirements of Canada, EMEA, USP, Pharmacopoeia, internal and EM sites requirements.

• Collect QA metrics on the specifications/ test methods process performance/ Enhance QA metrics.

• Support R&D to gain efficiency in specifications/test methods revisions update cycle time

What we are looking for

Required Qualifications

• A minimum of a Bachelor's degree or higher is required; degree concentration in Chemistry, Life Science, P...