QA Associate I-Investigations

Kenvue•Fort Washington, WA

2d•$61,880 - $87,360•Onsite

About The Position

Kenvue is currently recruiting for a: QA Associate I-Investigations 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: Supervisor 1, Quality Assurance Location: North America, United States, Pennsylvania, Fort Washington Work Location: Fully Onsite What you will do The QA Associate I – Investigations is accountable to supporting the investigation and CAPA process that pertains to the QC laboratories, facilities, manufacturing and packaging operations in addition to guidance on compliance and Good Manufacturing Practice (GMP) to meet company procedures, standards and regulatory expectations. This position assures that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures. Supports multiple functions in providing sound and timely decision making by utilizing root cause analysis, statistical, and problem-solving tools. Through the investigation process, this position will identify significant compliance issues and prioritize for action. Responsible for supporting the monitoring of investigation and CAPA systems, effectiveness, and continuous improvement of the Investigation /CAPA system at the Fort Washington site and Network / Global levels, as required. Ensures Investigation / CAPA Corrective and preventative Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (cGMP) regarding quality methods and manufacturing and packaging processes and procedures. Ensures that the process meets all internal and regulatory quality standards.

Requirements

Bachelor's degree in a relevant field or equivalent.
Requires 0-2 Years Work Experience
Prior experience in liquid manufacturing in an OTC or Pharmaceutical facility. (Plant QA experience preferred)
Experience with working effectively in a team-based environment.
Good problem-solving skills, willing to dig deep to understand underlying issues.
Excellent written and verbal communication skills.
Self-directed to manage priorities and adhere to deadlines
Clear and effective communication skills
Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint)

Nice To Haves

Familiarity with quality systems, regulations, and business impact.
Understanding of quality frameworks and processes.
Experience with audits, inspections, and corrective action plans.
Experience with LIMS, SAP, and EtQ is preferred.

Responsibilities

Initiates deviations, performs root cause analysis, conduct investigations to assess impact on products and process, recommends product disposition and recommends change controls and CAPA’s as needed.
Investigate process deviations through discussion with all applicable parties, such as: Manufacturing Ops, Tech Ops, Packaging Ops, and Maintenance.
Draft reports to summarize the details surrounding the deviations for input into the EtQ Symphony system.
Prepare draft investigations and investigational protocols as required.
Ensure all investigations are drafted to meet site specified timelines and are completed prior to release of associated product(s).
Make recommendations for corrective and/or preventative actions and discuss with applicable parties, such as: Manufacturing Ops, Tech Ops, Packaging Ops, and Maintenance.
Participate in cross functional meetings related to investigations, CAPAs and product disposition as applicable to assist in identifying and eliminating daily challenges on compliance that affect the quality of the product.
Assist in monitoring corrective/preventative measures to confirm effectiveness.
Assist QA Release group and Operations to determine/understand their needs in order to support investigations.
Participate in other projects/initiatives as assigned.