Quality Assurance 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:

QA Technical Lead

Location:

North America, United States, Pennsylvania, Fort Washington

Lugar de trabajo:

Totalmente in situ

What will you

The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. 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.

As a QA Associate I, you will:

• Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.

• Provides leadership support to QA Shop Floor activities including communication of quality events to management.

• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.

• Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.

• Performs or supports activities related Line Audits, Line or Area Cleaning Verifications

• Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).

• Provides support to Consumer Complaint investigations.

• Provide QA support to various project teams, as needed.

• Actively supports Site metrics, compliance improvement and training initiatives.

• Provide support to capturing of site metrics and promote improvement opportunities.

• Facilitate resolution of issues to improve site metrics.

• Represents Quality Assurance in positive manner

• Performs other related duties as required.

Qualifications

Required:

• Minimum of B.S. / B.A. Degree is required, a Science or technical field is preferred

• Minimum of 0-3 years of pharmaceutical industry quality experience, with shop floor experience

• Proven success in quality systems/compliance improvement

• Active cGMP interpretation and application experience

• Batch Record Review experience

• Problem solving/investigation experience

• Expertise in handling multiple priorities

• Strong organizational, communication/interpersonal and facilitation Skills (verbal, written and presentation)

• Requires up to 10% travel required based on business demands

• Ability to be based in Fort Washington, PA and requires up to ten percent (10%) of travel

• Ability to work (2) 12 hour shifts on weekend and (2) 8 hour shifts during the week

Preferred

• Process and Systems Experience, especially with MBRs, Change Controls, and Non-Conformance Investigation Documentation required

• Experience with Liquid Dose processing and packaging technology

What's in it for you

$0,00 - $0,00

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.