Quality Systems Specialist II

Kenvue is currently recruiting for:

Quality Systems Specialist II

This position reports to Manager Quality Systems 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: Manager Quality Systems

Location: Fort Washington PA

Travel %: none

What you will do

The Quality Systems Specialist II is responsible for executing Document Management, Retention and Training processes in support of ongoing projects and daily GMP/GDP operations for Fort Washington Plant. Primary responsibilities include the development, coordination and maintenance of all site documentation and training activities. This position requires a thorough knowledge of documentation, training and retention requirements. S/He may act as a SME for one or more business processes, will provide support to internal stakeholders and establish strong relationships to ensure efficient process.

Key Responsibilities

• Ensuring quality and compliance in GMP training, and identifying, reporting and seek corrections for deviations.

• Review/approve training documentation to ensure best practices of adult learning are applied while

• meeting customer needs.

• Collaborate with multiple functional areas (one-on-one or in a group setting), to develop standard, efficient processes and policies.

• Deliver training and/or support local Subject Matter Experts providing training, as needed. Including, but not limited to: GMP Orientation, Train-the-Trainer (T3) and routine GMP courses.

• Perform Learning Management System (LMS) transactions including user, item and curricula

• management, report generation and maintenance of content and completions.

• Perform document control activities to ensure GMP documents (controlled documents, logbooks) are managed as required by SOP and regulatory requirements.

• Support operational activities, including document issuance, reconciliation, reviewing and processing in the document management system. Provide support for the development of document templates, technical editing and formatting as needed.

• Serve as an administrator in the Electronic Records Management System (ERMS) which includes entering records, querying the system, filing and reporting metrics. Support and/or perform system validation/migration activities. Monitor functionality and communication between systems and related application.

• Support stakeholders by performing database searches, file retrieval, scanning & copying.

• Perform all task related to the document control room (Vault), receive, log and file, all documentation received in the Document Control Area.

What we are looking for

Required Qualifications

• Bachelor's Degree in a related field

• 2-4 years experience in a cGMP regulated environment

• Knowledge of FDQA, EMA and cGMP regulations

Desired Qualifications

• Experience with pharmaceutical/OTC manufacturing is preferred

• Some experience in training 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.

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