Operations Quality Lead

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

位置：

工作地點：

你會做什麼

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

對您有什麼好處

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。