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...
- Rate: Not Specified
- Location: Fort Washington, US-PA
- Type: Permanent
- Industry: Finance
- Recruiter: Johnson & Johnson Consumer Inc.
- Contact: Not Specified
- Email: to view click here
- Reference: 2407026126W
- Posted: 2024-10-02 08:17:08 -
- View all Jobs from Johnson & Johnson Consumer Inc.
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