Quality Systems Analyst

Kenvue•Fort Washington, PA

3d•Hybrid

About The Position

Kenvue is currently recruiting for a: Quality Systems Analyst 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. Role reports to: MANAGER QUALITY SYSTEMS Location: North America, United States, Pennsylvania, Fort Washington Work Location: Hybrid What you will do Under the direction of functional area management, the Quality System Specialist I is responsible for executing Document Management, Retention and Learning Management activities in support of ongoing projects. Primary responsibilities include the data entry, development, coordination and maintenance of all site documentation and training activities. This position requires a thorough knowledge of documentation, training, and retention requirements.

Requirements

Associate’s degree or equivalent work experience.
0-2 years of experience in a pharmaceutical cGMP/manufacturing environment.
Proficiency with MS Office, including Word, Excel and PowerPoint, Adobe, SharePoint and ability to learn new systems

Responsibilities

Perform Learning Management System (LMS) transactions including user, item and curricula management, report generation and maintenance of content and completions.
Monitor system through reporting functions to drive completion of outstanding items.
Perform document control activities to ensure GMP documents (controlled documents, logbooks) are managed as required by SOP and regulatory requirements.
Perform operational activities, including document issuance, reconciliation, review and processing in the document management system.
Provide support for the development of document templates, technical editing and formatting as needed.
Monitor system/workflow documentation and drive completion of tasks/outstanding items and ensure compliance
Ensure adherence to the corporate Records Retention Program and maintain site Records Retention Schedules.
Execute local and corporate SOPs to ensure chain of custody and traceability of all GMP records.
Support stakeholders by performing database searches, file retrieval, scanning & copying.
Serve as an administrator in the records management system 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 applications.