QA Associate I

QA Associate I

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

Quality Assurance Supervisor, Day Shift

Location:

North America, United States, Pennsylvania, Fort Washington

Lugar de trabajo:

Totalmente in situ

What will you

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

Esto tiene en cuenta una serie de factores que incluyen la ubicación del trabajo, las habilidades del candidato, la experiencia, el nivel de educación y otros factores relacionados con el trabajo.

Kenvue se enorgullece de ser un empleador que ofrece igualdad de oportunidades. Todos los solicitantes calificados recibirán consideración para el empleo basada en el mérito sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, edad, origen nacional o estado de veterano protegido y no serán discriminados por motivos de discapacidad.