Senior QA Supervisor

Kenvue Inc.; Las Piedras (PR); On-site; USD 91,000 - 128,000; Full time

Benefits offered by this job

Competitive benefits package

Paid company holidays

Volunteer time

Learning & development opportunities

Kenvuer Impact Networks

Job summary

Kenvueは北米地域のラスピエドラス拠点でSenior QA Supervisorを募集しています。品質システムの遵守と製造プロセスの監督、QAオペレーションの改善を主導します。多くの分野のQA経験と監督経験が求められ、現場での指導力が重要です。

英語とスペイン語の両方での高いコミュニケーション能力と、cGMPの深い理解が必要です。オンサイト勤務で、チームと協力して品質の高い製品を保証します。

Qualifications

• 専攻分野の学士号を有すること（化学、薬学、微生物学、生物学、または経営学）
• QA/製造環境で8年以上の経験、うち4年以上の監督経験が要件
• 英語とスペイン語のバイリンガル能力が望ましい
• cGMP/検証プロセスの知識と統計的手法の理解が求められる

Responsibilities

• 品質システムの遵守を確保する。
• 製造工程の文書とQA対応を監督・承認する。
• PA/QAオペレーションの現場を指導・調整する。
• CAPAの実施と検証、監査対応をサポートする。

Skills

Bilingual (English & Spanish)

Leadership

Quality assurance

Problem solving

Education

Bachelor of Science in Chemistry/Pharmacy/Microbiology/Biology or Business Administration

Tools

Microsoft Office

Job description

Kenvueは現在、a:

Senior QA Supervisor

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をクリックしてください。

Role reports to:

Site Quality Director

Location:

North America, United States, Puerto Rico, Las Piedras

勤務地:

フルオンサイト

あなたがすること

The Senior QA Supervisor ensures compliance with quality systems as established in applicable standards, policies, procedures, processes, specifications, related to the quality and manufacturing processes, procedures, and methods.

Assures the effective planning, coordination, and guidance in the review and approval of product between Downstream/Upstream stages, final disposition of bulk transfers, and finished product lots. Supports the assessment of documentation and systems associated to the manufacturing and packaging processes of batches prior to assigning their final product disposition as required. Communicates and updates the QA Associates on the quality metrics to identify improvement areas and implement the required changes.

Accountable for the printed material dispatch/return process to support packaging line operations, environmental conditions and housekeeping in the Label Room and the Reject (DO) cage.

Coordinates and supports the Downstream/Upstream operational areas’ shop floor activities by providing guidance to the QA and Operations group ensuring compliance with established procedures and business plans. Reviews and approves procedures and any other document when needed. Approves master batch records, start-up protocols and change controls when necessary.

Coordinates issuance of product holds with the distribution centers. Prepares and approves protocols, supports area investigations, develops and implements corrective actions/preventive actions (CAPAs) pertaining to the Quality Assurance Operations’ responsibilities.

Responsibilities

• Recruits, evaluates, supervises, applies disciplinary actions, provides recognition, develops and rewards employees under supervision.
• Develops and maintains QA Operation’s unit goals in alignment with the Quality Unit and site goals.
• Ensures cross training program is in place to maintain workforce flexibility.
• Prepares, coordinates and documents trainings to new personnel in tasks related to the position. Implements cross-training and development opportunities for personnel.
• Identifies opportunities for new techniques, procedures and evaluates new processes/ equipment needed to perform the work more efficiently.
• Reviews and updates area, forms, protocols, and procedures to ensure cGMP compliance.
• Conducts staff meetings to communicate quality, policies, safety, business, and human resources information.
• Designs, develops, and presents Quality Assurance project results and organizational business plans.
• Prepares and conducts departmental personnel headcount analysis using activity-based model and volume forecast.
• Participates in internal and external business-related committees as applicable.
• Identifies need for and writes corrective action/preventive action (CAPA) related to QA Operation’s unit.
• Approves investigations and CAPAs related to functional area as required.
• Serves as area manager back-up including but not limited to attending meetings such as the Quality Council among other.
• Provides support to projects.
• Provides internal/external audit support.
• Participates in validation, protocol, and change control design processes to ensure product hold when applicable.
• Ensures compliance and employee engagement with EHS&S policies and programs.

Requirements

• Education: Bachelor of Science preferably in Chemistry, Pharmacy, Microbiology or Biology, or a bachelor’s degree in business administration.
• Experience: Eight or more years of experience in quality assurance with at least four years at a supervisory levelin the quality assurance and/or manufacturing environment, not limited to: pharmaceutical solid and liquid dosage, OTC, and controlled product manufacturing, packaging, incoming, audits, compliance, and product disposition.
• Physical Demands: Sedentary work that requires minimum physical effort. It also requires communication skills, and eye hand coordination and the ability to move. Visual discrimination: closeness and at a distance.
• Knowledge, Skills and Abilities: Bilingual (English and Spanish) with excellent verbal, writing and technical writing skills in both languages. Ability to interpret and apply current Good Manufacturing Practices. Mathematics skills and analytical ability. Knowledge and skills in validation processes and statistical process control, detection, correction and error prevention, and process system challenges. Sampling process, audit, root cause analysis and risk management knowledge. Basic computer knowledge (Microsoft Office software - Excel, PowerPoint, Word). Must be able to make decisions using critical thinking and decision-making tools based on facts at hand while meeting established deadlines and priorities. Demonstrated leadership and organizational skills. Well versed in the latest quality assurance techniques; possesses the ability to develop and implement plans to drive quality improvement and to make decisions to drive compliant business results.
• Certifications/Licenses: None.
• Leadership: Incumbent should demonstrate solid competencies on the values and behaviors to effectively contribute to the transformation of the scope of work.
• Other Requirements: Able to travel in and outside of Puerto Rico. Able to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business. Able to support other departments and/or projects according to business needs.

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:

$90,950.00 - $128,400.00

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。