QA Associate I

QA Associate I

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

Rollenberichte an:

Quality Assurance Supervisor, Day Shift

Ort:

North America, United States, Pennsylvania, Fort Washington

Arbeitsort:

Vollständig vor Ort

Was Sie tun werden

The QA Associate I – 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.

Key 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.

Other Support Functions

·         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.

What we are looking for

Required Qualifications

·         Bachelor's degree in a relevant field or equivalent qualification in Engineering, Science, or a related field.

·         Requires 0-2 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)

Desired Qualifications

·         2 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.

·         Experience with GMP.

Shift

12-hour rotating workweek, structured around combinations such as two days on/two days off and three days on/three days off.

100% onsite, every scheduled workday. 

#LI-ND1

Was haben Sie davon

$61,880.00 - $87,360.00

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

Kenvue ist stolz darauf, ein Arbeitgeber für Chancengleichheit zu sein. Alle qualifizierten Bewerber werden unabhängig von Rasse, Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, Alter, nationaler Herkunft oder geschütztem Veteranenstatus für eine Beschäftigung in Betracht gezogen und nicht aufgrund von Behinderung diskriminiert.