Operations Quality Lead

Operations Quality Lead

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Business Unit Manager, Personal Care

Location:

North America, United States, Pennsylvania, Lititz

勤務地:

フルオンサイト

あなたがすること

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

それは何ですか

$90,100.00 - $127,200.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。