QA Associate II-Plant Quality Operations, Day Shift

Kenvue

2d•Onsite

About The Position

Kenvue is currently recruiting for a: QA Associate II-Plant Quality Operations, Day Shift 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 II – Plant Quality Operations is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Primary responsibility for this role is Batch Records Review and Product Release. Additional QA support areas include but are not limited to Shop Floor, Standard Operating Procedures, Investigations, CAPA, Change Control, and Shop Floor Walkthroughs. 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. Responsible for ensuring compliance with company policies, procedures, and quality standards, as well as safety and environmental regulations. Provides daily support to product review and release functions. Writes and assists others in writing standard operating procedures.

Requirements

Bachelor's degree in a relevant field or equivalent qualification in Engineering, Science, or a related field.
Requires 2-4 Years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement within manufacturing or plant operations.
Experience with working effectively in a team-based environment.
Strong Organizational Skills
Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
Expertise in Handling Multiple Priorities
Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint)

Nice To Haves

4 years professional experience in a regulated industry
Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
Experience with Liquid Dose processing and packaging technology preferred
Familiarity with quality systems, regulations, and business impact.
Experience with LIMS, SAP, and EtQ is preferred.

Responsibilities

Performs or supports activities related to Batch Record Review and Disposition of Raw Material, Bulk, and Finished Product.
Performs or supports activities related to SUI Authorization, Reconciliation and Shipping Order Processing.
Performs or supports activities related to Material Reconciliation, Material Holds, DO Processing and X-Batch Creation.
Performs or supports activities related to APR Contributions for Raw Materials and Finished Goods.
Performs or supports activities related to cMAT and sMIC creation and workflows.
Performs or supports activities related to Maximo QARR Approvals.
Performs or supports activities related to design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
Provide support to capturing of site metrics and promote improvement opportunities.
Facilitate resolution of issues to improve site metrics.
Provides training and direction as needed to new employees.
Teams with Department members for process feedback and continuous improvement opportunities.
Performs or supports Shop Floor activities related to Equipment Status Updates, GMP Walk Throughs, Material Issuance and Line or Area Cleaning Verifications as needed.
Provides support to QA Shop Floor including responding to quality events and escalation to management as needed.
Provide QA support to various project teams, as needed.
Represents Quality Assurance in positive manner.