QA Associate II-Plant Quality Operations, Day Shift

QA Associate II-Plant Quality Operations, Day Shift

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

Supervisor 1, Quality Assurance

Location:

North America, United States, Pennsylvania, Fort Washington

Место работы:

Полностью на месте

Что ты будешь делать

The QA Associate II – 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 2-4 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

• 4 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.

#LI-SR1

Что в этом для тебя

$72,675.00 - $102,600.00

Это учитывает ряд факторов, включая место работы, навыки, опыт кандидата, уровень образования и другие факторы, связанные с работой.

Kenvue гордится тем, что является работодателем равных возможностей. Все квалифицированные кандидаты будут рассматриваться при приеме на работу на основе заслуг независимо от расы, цвета кожи, религии, пола, сексуальной ориентации, гендерной идентичности, возраста, национального происхождения или защищенного статуса ветерана, и не будут дискриминироваться по признаку инвалидности.