Specialist, R&D Quality & Compliance

Kenvue Inc.; Summit (NJ); Hybrid; USD 82,000 - 116,000; Full time

Benefits offered by this job

Competitive benefits package

Paid holidays and vacation

Volunteer time off

Learning & development opportunities

Kenvuer Impact Networks

Job summary

Kenvue Inc. is seeking a Specialist, R&D Quality & Compliance in Summit, NJ with a hybrid work setup. You will administer integrated quality systems to ensure R&D activities meet cGMP standards and company procedures, including documentation reviews and audits.

Responsibilities include inspection readiness, cross-functional collaboration on GMP documentation, training, and quality metrics reporting across NA sites. A strong emphasis on regulatory guidance and process improvements is required.

Qualifications

• Bachelor's degree or equivalent experience in a relevant field.
• 2–4 years in pharmaceutical, cosmetics, consumer products, or FDA-regulated environment.
• Proven ability to work effectively in a team-based environment.
• Strong organizational and communication skills; ability to handle multiple priorities.
• Proficiency with Word, Excel, PowerPoint.

Responsibilities

• Review and approve GMP documentation and batch records.
• Conduct quality inspections of supplies for R&D studies.
• Serve as Quality representative on R&D project teams.
• Provide GMP regulatory guidance and training.
• Maintain GMP documentation, storage and archival processes.
• Support GMP/Q&C procedure development and process improvements.
• Perform internal assessments and support inspection readiness.
• Collect and report NA R&D Quality metrics monthly and semiannually.
• Coordinate documentation for pre-audit requests and audit readiness.

Skills

Teamwork

Organizational skills

Communication

Multi-tasking

MS Office

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Office Suite

Job description

Specialist, R&D Quality & Compliance

Kenvueは現在、a:

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hereを確認してください。

Role reports to: Sr Mngr RD Quality & Compliance

Location: North America, United States, New Jersey, Summit

勤務地: ハイブリッド

あなたがすること

What you will do

The Specialist, R&D Quality & Compliance (R&D Q&C)is responsible foradministering integrated and comprehensive quality systems and controls to ensure R&D functionsoperatein compliance with sound scientific practices, cGMP requirements, and company procedures.Responsibilities include documentation review and approval, audits, inspections, archival activities, internal assessments, support of R&D study releases, and regulatory guidance.

Key Responsibilities

• Review and approve GMP documentation and batch records, including laboratory batches with process controls.
• Conduct quality inspections of supplies for R&D studies.
• Serve as Quality representative on R&D project teams.
• Provide GMP regulatory guidance and training.
• Maintain GMP documentation,storageand archival processes.
• Participatein GMP/Q&C procedure development, revision, and implementation, and support related process improvements.
• Perform internal assessments and support inspection readiness.
• Collect, compile, and report North America R&D Quality metrics across Kenvue sites (monthly & semiannual).
• Support internal and GRC audit preparation and execution; including coordinating and gathering documentation for pre-audit requests.
• Manage non-marketed product quality complaints in accordance with applicable procedures.
• Assistin compiling documentation for R&D study release andinspectionreadiness activities.
• Provide additional training and procedural guidance to R&D personnel on Quality processes & GMP documentation.
• Identify and escape quality and compliance gaps with assigned areas of responsibility.

What we are looking for

Required Qualifications

• Bachelor's degree in a relevant field or equivalent experience.
• Requires 2-4 Years in pharmaceutical, cosmetics, consumer products, or FDA-regulated environment.
• Experience with working effectively in a team-based environment.
• Strong Organizational Skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Expertise in Handling Multiple Priorities
• Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint)

Desired Qualifications

• Developing Product development process experience; knowledge of cGMP/cGLPrequirements for cosmetic, OTC, and medical device products.

それは何ですか

このポジションの新入社員の年間基本給の範囲:

$82,025.00 - $115,800.00

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.

• 競争力のある福利厚生パッケージ*
• 有給の会社の休日、 有給休暇、ボランティアタイム&詳細!
• 学習&開発の機会
• Kenvuer Impact Networks
• このリストは場所/地域によって異なる場合があります

*注:Kenvueの合計報酬には、給与、ボーナス(該当する場合)、および福利厚生が含まれます。あなたのタレントアクセスパートナーは、採用および採用中に、関連する場所の報酬提供総額と特定の給与範囲について詳しく共有することができます。採用プロセス.

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。

障害を持つ個人の方は、宿泊施設のリクエスト方法について、私たちの障害者支援ページを確認してください。