Quality Assurance Associate I

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

QA Technical Lead

Location:

North America, United States, Pennsylvania, Fort Washington

Local de trabalho:

Totalmente no local

O que você fará

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

O que você ganha com isso

$0,00 - $0,00

Isso leva em consideração vários fatores, incluindo local de trabalho, habilidades do candidato, experiência, nível de educação e outros fatores relacionados ao trabalho.

A Kenvue tem orgulho de ser um empregador de oportunidades iguais. Todos os candidatos qualificados serão considerados para o emprego com base no mérito, independentemente de raça, cor, religião, sexo, orientação sexual, identidade de gênero, idade, nacionalidade ou status de veterano protegido e não serão discriminados com base na deficiência.