QA Associate III - Investigations

QA Associate III - Investigations

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 III – Investigations is accountable to support the investigation and CAPA process that pertains to the QC laboratories, facilities, manufacturing and packaging operations in addition to guidance on compliance and Good Manufacturing Practice (GMP) to meet company procedures, standards and regulatory expectations. This position provides daily direction, planning, decision making and compliance focus for the site consistent with Supply Chain Goals while meeting the compliance goals of Quality Assurance. Supports multiple functions in providing sound and timely decision making by utilizing root cause analysis, statistical, and problem-solving tools. Through the investigation process, this position will identify significant compliance issues and prioritize for action. Lead and implement improvement opportunities and problem solutions.

Responsible for reviewing, approving, and ensuring investigations and CAPA are completed timely and in alignment with standard operating procedures. Responsible for the administration of investigation and CAPA systems, effectiveness, and continuous improvement of the Investigation /CAPA system at the Fort Washington site and Network / Global levels, as required. Responsible for administration of Investigation and CAPA metrics management and review board. Measures, tracks, trends and promotes improvement of process metrics.

Ensures Investigation / CAPA Corrective and preventative Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (cGMP) regarding quality methods and manufacturing and packaging processes and procedures. Ensures that the process meets all internal and regulatory quality standards.

Key Responsibilities

• Lead and facilitate investigations and relative improvement projects and initiatives identified root cause analyses.
• Evaluate non-conformance investigations provided by functional areas assuring that all appropriate investigation steps were conducted and that appropriate corrective actions were devised where applicable.
• Consult with the functional areas to align cGMP requirements, company, and regulatory guidelines.
• Maintain knowledge of regulatory environment, cGMPs, FDA policies and current industry trends.
• Prepare and present written and verbal reports to upper management pertaining to investigation and CAPAs.
• Participate in cross functional meetings related to investigations and CAPA and product disposition as applicable to identify daily challenges on compliance that affect the quality of the product.
• Engage vendors in investigations that pertain to the quality of finishing supplies or raw materials and assure that corrective actions are devised where applicable.
• Author investigations and investigational protocols as required.
• Ensure all investigations are drafted to meet site specified timelines and are completed prior to release of associated product(s).
• Perform and understand investigation trending in order to determine appropriate CAPA’s in response to trends.
• Ensure investigation metrics and trends are available for presentation during regulatory inspections and inclusion in APRs.
• Author Annual Product Review contributions related to investigations and CAPA. Review and approve APR contributions as required.
• Assist in managing investigations and CAPA implementations.
• Initiates deviations, performs root cause analysis, conduct investigations to assess impact on products and process, recommends product disposition and recommends change controls and CAPA’s as needed.
• Participate in daily/weekly event meetings providing updates and follow-up to manage process & schedule.
• Interacts with QA Release group and Operations to determine/understand their needs in order to resolve investigations.
• Assist in the site internal audit program when required.
• Work closely with the correction/CAPA owners to remediate events and/or corrections /CAPA’s necessary to close out the investigation.
• When necessary based on the investigation to be performed, ensure and coordinate involvement of cross functional teams with appropriate expertise
• Ensure site SOPs accurately reflect the investigation process and update as necessary.
• Assist in resolution of roadblocks that prevent optimal effectiveness of the investigation process.
• Work with other corporate units as required.

What we are looking for

Required Qualifications

• 4-6 years of experience in quality assurance or related field
• Bachelor's degree in a relevant field or equivalent
• Working knowledge of pharmaceutical facilities, equipment, laboratories and systems is required. 
• Experience with Microsoft based Office applications is required.
• Strong written communication skills required

Desired Qualifications

• Strong analytical skills with the ability to interpret complex data sets
• Excellent communication and interpersonal skills to collaborate effectively with diverse teams
• Proven track record of leading investigations and implementing corrective actions
• Familiarity with quality systems, regulations, and business impact
• Solid understanding of quality frameworks and processes
• Experience with audits, inspections, and corrective action plans
• Experience with LIMS, SAP, and EtQ is preferred

Что в этом для тебя

$0.00 – $0.00

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.