[innovative Medicine] Analyst, Quality … at Johnson & Johnson

What you'd actually do

Manage the full lifecycle of laboratory instruments and related software, including selection, qualification at deployment and upon changes, calibration, troubleshooting, and decommissioning.

Drive alignment with HA/global data integrity requirements for laboratory instruments and associated software by assessing gaps, conducting risk assessments, and implementing risk mitigation measures.

Perform administrator tasks such as backup and restore, user access reviews, periodic reviews, and the administration of SMDS and Deskman for lab equipment.

Prepare for GMP/GCTP audits and proactively support the identification of compliance risks and deviations.

Lead lab optimization projects to improve productivity and reduce cost, cycle time, inventory, and errors, achieving agreed financial targets.

Skills

Required

Bachelor's degree or equivalent education in science, chemistry, biology, biotechnology, microbiology, or related fields.
Over 2 years of work experience in the pharmaceutical industry
GMP/GCTP and Data integrity
Pharmaceutical regulations, standards, and guidelines
Experience in analytical testing, instrument analysis, and equipment management.
Ability to use basic PC software, including Microsoft Office.
Good communication skills in English (both written and verbal)

Nice to have

Prior experience performing equipment qualification (IQ/OQ/PQ) in a GxP‑regulated environment is highly desirable.
Experience in project management
Ability to communicate effectively in Japanese.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

**Job Function: **

Quality

**Job Sub Function: **

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Shizuoka, Japan

Job Description:

**About Innovative Medicine **

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

主な職務及び責務** Major Job Duties and Responsibilities:**

ラボ機器及び関連するソフトウェアのライフサイクル管理（選定、導入時/変更時適格性評価、キャリブレーション、トラブルシューティング廃棄）
ラボ機器及び関連するソフトウェアに関するデータインテグリティ要件について、当局・グローバル要求事項とのギャップのアセスメント、リスク評価、リスク低減策の実施等を通じて要求事項との調和を実現する。
バックアップ/リストア、ユーザーアクセスレビュー、定期的なレビュー、SMDS、Deskman管理などの試験機器に関するアドミニストレータータスクを実行する。
安全・規制要件に準拠し、トレーニングマトリックスに定義されたGMP/GCTP、EHS、および業務に必要な教育訓練を受講する。
GMP/GCTP監査の準備を実行し、コンプライアンスリスクや逸脱の特定を積極的にサポートする。
ラボにおける生産性の向上、コスト・サイクルタイム・在庫の削減、エラーの削減等を通じた最適化PJをリードし、ファイナンス目標を達成する。
品質管理マネージャー、スーパーバイザーまたはラボリードによってアサインされたその他の業務を実行する。
Manage the full lifecycle of laboratory instruments and related software, including selection, qualification at deployment and upon changes, calibration, troubleshooting, and decommissioning.
Drive alignment with HA/global data integrity requirements for laboratory instruments and associated software by assessing gaps, conducting risk assessments, and implementing risk mitigation measures.
Perform administrator tasks such as backup and restore, user access reviews, periodic reviews, and the administration of SMDS and Deskman for lab equipment.
Complete all training defined in the training matrix, including GMP, GCTP, EHS, and other role-required trainings; operate in full compliance with safety and regulatory requirements.
Prepare for GMP/GCTP audits and proactively support the identification of compliance risks and deviations.
Lead lab optimization projects to improve productivity and reduce cost, cycle time, inventory, and errors, achieving agreed financial targets.
Perform other duties as assigned by the Quality Control Manager, Supervisor, or Lab Lead.

職務の要件** Job Requirements:**

教育/経験Education and Experiences:

科学、化学、生物学、バイオテクノロジー、微生物学、関連分野の学士号もしくは同等の教育
医薬品業界における 2 年以上の業務経験
Bachelor's degree or equivalent education in science, chemistry, biology, biotechnology, microbiology, or related fields.
Over 2 years of work experience in the pharmaceutical industry

知識、資格、及び技能 Knowledge, Qualification and Skills:

GMP/GCTP とデータインテグリティ
医薬品の規制、基準、およびガイドライン
分析試験/ 機器分析/ 機器管理の経験。GxPでの機器適格性評価の経験があればなお良い
Microsoft Office などの基本的な PC ソフトウェアプログラム
英語でのコミュニケーション（メール/会議/文書作成）
推奨：プロジェクトマネージメントの経験、日本語でのコミュニケーション
GMP/GCTP and Data integrity
Pharmaceutical regulations, standards, and guidelines
Experience in analytical testing, instrument analysis, and equipment management. Prior experience performing equipment qualification (IQ/OQ/PQ) in a GxP‑regulated environment is highly desirable.
Ability to use basic PC software, including Microsoft Office.
Good communication skills in English (both written and verbal)
Preferred skills: Experience in project management, and ability to communicate effectively in Japanese.

行動特性 Core Competencies:

確固たるクレド―バリュー
EHS 規則と手順の遵守
すべてのインシデント、事故、およびニアミスイベントの報告
コラボレーションとチームワーク
Credo value of integrity
Compliance with EHS rules and procedures
Report all incidents, accidents, and near missed events.
Collaboration and teamwork

#LI-Onsite

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社内公募ガイドライン

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**Required Skills: **

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Execution Focus, ISO 9001, Issue Escalation, Performance Monitoring, Persistence and Tenacity, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection