[Innovative Medicine] Quality Control Group Analyst, Quality Operations Dept., Fuji Plant, Manufactu

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* Responsible for implementation, improvement and harmonization of laboratory quality systems.


* Responsible for ensuring all laboratory systems comply with GMP/GCTP and J&J guidelines and quality standards, including support to regulatory filings and sub-system owner for laboratory systems.


* Perform the activities, encompassing activities in support of laboratory systems, e.g.

equipment qualification, compendia and quality standard review, stability program administration, analytical change control, LIMS, Empower, training, etc.


* Leads and supports projects within laboratories aimed at improving on financial targets, efficiencies and productivities achieving increasing agility and flow throughput, reducing cost, cycle time, inventory reduction, performance improvement and error reduction.


* Ensures required GMP/GCTP, EHS and role-related training required to work safely and in compliance with regulatory requirements and as defined by their training matrix.


* Proactively supports GMP/GCTP compliance, permanent audit readiness, identification of compliance risks and breaches.


* Any other duties as assigned by the Quality Control Manager or Lab Lead.



* ラボの品質システムの実装,改善,調和に責任を持つ。


* すべてのラボ システムが GMP/GCTP および J&J ガイドラインおよび品質基準に準拠していることを確認する責任がある。これには,ラボ システムの規制当局への提出やサブシステム オ-ナ-へのサポ-トも含まれる。


* 試験室システムを支援する活動を実施する。機器の適格性評価,公定書および品質基準のレビュ-,安定性試験プログラム管理,変更管理,LIMS,Empower,トレ-ニングなど。


* ファイナンス目標,効率性,生産性を向上させ,アジリティとフロ-スル-プットの向上,コストの削減,サイクルタイム,在庫の削減,パフォ-マンスの改善,エラ-の削減を目的としたラボ内のプロジェクトをリ-ドおよびサポ-トする。


* 安全かつ規制要件に準拠し,トレ-ニング マトリックスで定義されているとおりに作業するために必要な,必要な GMP/GCTP,EHS,および役割関連のトレ-ニングを受ける。


* GMP/GCTPコンプライアンス,恒久的な監査準備,コンプライアンス リスクと違反の特定...