Quality Specialist
Kenvue NA

Job Info

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Kenvue is currently recruiting for:

Quality Specialist

This position reports to External Quality Lead 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: External Quality Lead

Location: Fort Washington, PA

Travel %: none

What you will do

The The Quality Specialist provides support in the management of contract laboratories investigations at external partners, qualification and disengagement of contract laboratories. Develops and monitors mitigation plans to remediate risk for laboratories performance. Works with Micro COE to support microbiological investigations and method suitability reports at contract laboratories. Partners with R&D, internal sites for technical transfers for external suppliers.

Key Responsibilities:

• Conduct micro data package reviews for contract laboratories

• Coordinate and drive laboratory investigations at external partners

• Provide support in laboratory qualification/disengagement, change control writing, quality agreement periodic review.

• Write micro suitability reports and micro assessments

• Revise relevant SOP's which govern the assessment program.

• Seek management alignment on mitigation plans

• Develops mitigation plans to remediate risk for contract laboratories

• Provide technical expertise regarding the interpretation and/or implementation of cGMP practices. Provide technical input for remedial action plan development.

• Provides procurement support and quote negotiations

• Review and approve validation approaches/protocols and reports ensuring compliance to regulatory and company requirements as needed.

• Train personnel on laboratory compliance.

• Highly analytical and able to understand, analyze, and interpret scientific, technical information.

What we are looking for

Required Qualifications

• A minimum of a Bachelor's degree or higher is required.

• A minimum of six or more years of relevant work experience is required

• Detailed working knowledge of cGMP requirements and current FDA/ Health Canada enforcement issues is required.

• Proficiency in Microsoft Office tools (PowerPoint, Word, Excel and Outlook) is required.

• Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability required.

Desired Qualifications

• Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority required.

• Knowledge of CEDMS, TRU and EtQ is preferred.

• Bachelor's of Science or higher degree in Science with an emphasis in Microbiology is preferred.

• GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production is preferred.

What's in it for you

• Competitive Total Rewards Package*

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

#vhd

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