QA Specialist II; 2nd Shift

QA Specialist II (2nd Shift)

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。

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

Manager Plant Quality

North America, United States, Pennsylvania, Lititz

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Performs product release on 2nd shift after completing record review and assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures. Provides QA support to operations.

• Work with highly engaged and effective team.
• Perform quality review of production records including manufacturing, packaging, and laboratory documents.
• Responsible for releases of finished product based on conformance to established standards.
• Apply quality assurance processes, procedures, and activities.
• Conduct walkthroughs and assessments of GMP areas.
• Partner with Operations to address quality/compliance issues and improvements.
• Complete review of batch records for complaint investigations.
• Generate and distribute certificates of compliance to foreign affiliates.
• Review compliance records, specifications, procedures and other documents, as required by procedure. Limited approval responsibilities.
• Generate, identify and suggest improvements as well as improvements to quality and plant operations.
• Participate in and lead process improvement teams as appropriate.
• Maintain ownership and train others on applicable SOP’s. Write and assist others is writing new or updated operating procedures.
• Conduct low risk/low complexity investigations and rationales which are technically accurate and regulatory compliance focused for all quality documentation including non-conformances, corrective actions, CAPAs and audit observation responses, quality reports, metrics. QA management will provide support.
• Independent recommendations to Supervisor regarding compliance decisions with moderate potential impact to business.
• With oversight from manager, prioritize highly complex and diverse workload ensuring results are timely, accurate, and meet their intended objective.
• Assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits.

Ensure quality and compliance in all my actions by:

• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Adhere to strict compliance with procedures applicable to my role.
• Exercise the highest level of integrity in the tasks that I perform.
• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the…