Analyst 2, External Manufacturing QA

Description

Kenvue is currently recruiting for a:

Analyst 2, External Manufacturing QA

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:
Quality Account Manager

Location:
North America, United States, Pennsylvania, Fort Washington

Work Location:
Fully Onsite

What you will do

The Quality Analyst II is responsible for performing key activities related to the retain management, manufacturing, packaging, testing, and release of the portfolio of US Self Care drug products in the external supply chain of Kenvue.

This role represents External Manufacturing Quality Assurance (EMQA) on projects and improvement teams to guide quality/compliance requirements, develop and update procedures, and provides support to the Quality Leads and Account Managers for products produced across our network.

This is a fully onsite position in Fort Washington, PA.

Key Responsibilities:

• Support the processing of retention samples from external packaging sites.

• Support EMQA Quality Leads and Quality Account Managers through various projects and quality/compliance improvement activities and change controls within EMQA.

• Support batch record review and batch disposition for US Self Care drug products from external manufacturing and packaging sites.

• Support EMQA as a Tru admin with uploading documents in Tru

What are we looking for

Qualifications:

Education:

• Minimum of a Bachelor's degree required; focused degree preferred in Engineering, Life Science, Physical Science, or related subject area

Experience and Skills:

Required:

• Minimum 2 years of relevant work experience

• Experience in FDA-regulated pharmaceutical Quality or Supply Chain role

• Solid understanding of cGMPs

• Solid understanding of Quality Assurance principles and practices in the pharmaceutical, medical device, biological, and/or OTC Drug product industry

Preferred:

• Familiarity with LIMS & SAP

• Solid understanding of site quality activities (batch record review, product release, change control)

• Advanced proficiency with Microsoft Excel (e.g., VLOOKUPS and pivot tables)

• Experience ...