Operations Quality Lead

Operations Quality Lead

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Business Unit Manager, Personal Care

位置：

North America, United States, Pennsylvania, Lititz

工作地点：

完全现场

你会做什么

Supports Lititz and Network Quality Unit functions related to Investigation/CAPA and other GMP documents. This position provides daily direction, planning, and compliance focus for the Business Unit consistent with Supply Chain Goals while meeting the compliance goals of Quality Assurance.

Supports the activities of the site’s Investigation/CAPA program. Responsible for reviewing, approving and ensuring that INVs and CAPAs are completed, as stated in the standard operating procedures. Responsible for the administration, effectiveness and continuous improvement of the Business Unit's Investigation/CAPA system. Responsible for representing the Business Unit in CAPA Review Board for the site.

Ensures Investigation/CAPA 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. Provides compliance perspective and expertise to ensure that the process consistently meets all internal and Regulatory Quality standards.

Are you interested in joining a team in a fast-paced environment where we are working to improve the lives of our customers and employees? Apply today!!

Key Responsibilities:

• Conduct Root Cause analysis of the following: Manufacturing Deviations, Nonconformances, Change Control, INV/CAPA, Quality
• Technical writing: Quality investigations, Root Cause analysis investigation o Corrections (SOPs, Wis, JAs) o Quality Alerts
• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Supports Investigation/CAPA process
• Develops and Submits CAPA/Action Items, SOPs, specifications, Protocols/Report, Maintenance forms, and Investigations for cGMP compliance when appropriate.
• Participates in internal and external audits
• Acts as an SME for Investigation/CAPA process
• Provides cGMP compliance guidance and delivers training/capability building to the Business Unit
• Ensures the Business Unit is in compliance with the CAPA procedure and processes.
• Collaborates with functional areas in the data analysis of the quality indicators for trends. Ensures that systematic situations, trends and key performance measures are escalated to management or CAPA Review Board and prioritized according to the processes and risks involved.
• Provides real-time compliance consulting and expertise to the site.
• Ensures appropriate focus on compliance goals and issues at Daily Business Unit meetings.
• Actively supports compliance improvement and training initiatives.
• Measure, track, trend and promote improvement of process metrics.
• Performs other functions as required.

What We Are Looking For

Required Qualifications

• B.S. or B.A. College Degree (Science or Technical Degree preferred)
• 3-5 years Pharmaceutical Industry Quality/FDA Regulated Experience required, with proven success in quality systems/compliance improvement preferred
• Active cGMP Interpretation and Application Experience
• Demonstrated leadership- possesses the ability to lead by influence
• Strong Organizational Skills
• Ability to coordinate and delegate tasks
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Demonstrated proficiency with Problem Solving/Investigation required

Desired Qualifications

• Process Mapping experience
• Statistical Analysis experience
• Ability to work a flexible schedule and accommodate investigation/CAPA activities across multiple shifts as needed

对您有什么好处

$90,100.00 - $127,200.00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。