QA Specialist II (2nd Shift)

Kenvue Inc.; Lititz (Lancaster County); On-site; USD 73,000 - 103,000; Full time

Benefits offered by this job

Compensation package

Paid holidays & vacation

Volunteer time

Learning & development

Kenvue Impact Networks

Job summary

Kenvue Inc. in Lititz, PA is seeking a QA Specialist II on the 2nd shift to lead product release activities and ensure GMP/GxP compliance across manufacturing, packaging, and laboratory documentation.

You will partner with Operations, perform batch record reviews, and drive CAPAs and process improvements, while training others on SOPs and supporting regulatory audits. This role requires a Bachelor's degree and GMP experience in pharma/medical devices, with strong communication and analytical

Qualifications

• A minimum of a Bachelor's Degree.
• Minimum 2 years GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.
• Basic working knowledge of cGMP requirements and current FDA enforcement issues.
• Ability to communicate thoughts and ideas effectively – verbal and written.
• Demonstrated ability to accomplish work goals.

Responsibilities

• 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.

Skills

Communication

Analytical thinking

Quality mindset

Team collaboration

Education

Bachelor's Degree

Tools

Word

Excel

Job description

QA Specialist II (2nd Shift)

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

Manager Plant Quality

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

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.

Key Responsibilities

• 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.

All employees

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 job right the first time.

What we are looking for

Required Qualifications

• A minimum of a Bachelors Degree
• A minimum of 2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.
• Basic working knowledge of cGMP requirements and current FDA enforcement issues.
• Ability to communicate thoughts and ideas effectively – verbal and written.
• Demonstrated ability to accomplish work goals

Preferred Qualifications

• Proficiency in office productivity software, including advanced skills in Word and Excel
• Strong analytical skills to develop actionable quality strategies and ensure regulatory compliance
• Demonstrated ability to work independently and influence cross-functional teams without direct authority

#LI-SR1

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:

$72,675.00 - $102,600.00

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。