Quality Assurance Associate I

Kenvue•Fort Washington, PA

2d•Onsite

About The Position

Kenvue is currently recruiting for a: Quality Assurance Associate I 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: QA Technical Lead Location: North America, United States, Pennsylvania, Fort Washington Work Location: Fully Onsite What you will do The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities.

Requirements

Minimum of B.S. / B.A. Degree is required, a Science or technical field is preferred
Minimum of 0-3 years of pharmaceutical industry quality experience, with shop floor experience
Proven success in quality systems/compliance improvement
Active cGMP interpretation and application experience
Batch Record Review experience
Problem solving/investigation experience
Expertise in handling multiple priorities
Strong organizational, communication/interpersonal and facilitation Skills (verbal, written and presentation)
Requires up to 10% travel required based on business demands
Ability to be based in Fort Washington, PA and requires up to ten percent (10%) of travel
Ability to work (2) 12 hour shifts on weekend and (2) 8 hour shifts during the week

Nice To Haves

Process and Systems Experience, especially with MBRs, Change Controls, and Non-Conformance Investigation Documentation required
Experience with Liquid Dose processing and packaging technology

Responsibilities

Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.
Provides leadership support to QA Shop Floor activities including communication of quality events to management.
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
Provides support to Consumer Complaint investigations.
Provide QA support to various project teams, as needed.
Actively supports Site metrics, compliance improvement and training initiatives.
Provide support to capturing of site metrics and promote improvement opportunities.
Facilitate resolution of issues to improve site metrics.
Represents Quality Assurance in positive manner
Performs other related duties as required.