QA Associate I

QA Associate I

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Quality Assurance Supervisor, Day Shift

Locatie:

North America, United States, Pennsylvania, Fort Washington

Werklocatie:

Volledig ter plaatse

Wat je gaat doen

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

what's in it for you

$61,880.00 - $87,360.00

Hierbij wordt rekening gehouden met een aantal factoren, waaronder de werklocatie, de vaardigheden, ervaring, opleidingsniveau van de kandidaat & andere werkgerelateerde factoren.

Kenvue is er trots op een werkgever te zijn die gelijke kansen biedt. Alle gekwalificeerde sollicitanten komen in aanmerking voor een baan op basis van verdienste, ongeacht ras, huidskleur, religie, geslacht, seksuele geaardheid, genderidentiteit, leeftijd, nationale afkomst of beschermde veteranenstatus en worden niet gediscrimineerd op basis van handicap.