Senior QA Supervisor

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

位置：

工作地點：

你會做什麼

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 level in 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.

對您有什麼好處

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。