Senior QA Supervisor

Kenvue•Las Piedras, PR

6d•$90,950 - $128,400•Onsite

About The Position

The Senior QA Supervisor ensures compliance with quality systems and applicable standards, policies, procedures, processes, and specifications related to quality and manufacturing. The role plans, coordinates, and guides reviews and approvals of product between Downstream and Upstream stages, final disposition of bulk transfers, and finished product lots. It supports assessment of manufacturing and packaging batch documentation and systems before final product disposition, and communicates quality metrics to QA Associates to identify improvement areas and implement changes. The position is accountable for the printed material dispatch and return process supporting packaging line operations, as well as environmental conditions and housekeeping in the Label Room and Reject (DO) cage. It coordinates Downstream and Upstream shop-floor activities, guiding QA and Operations teams in compliance with procedures and business plans. The Senior QA Supervisor reviews and approves procedures and other documents, and approves master batch records, start-up protocols, and change controls as needed. The role also coordinates product holds with distribution centers, prepares and approves protocols, supports investigations, and develops and implements CAPAs. The role supervises and develops employees, maintains QA Operations goals, training, and cross-training programs, supports process and equipment improvement, and ensures cGMP compliance. It provides audit, project, validation, protocol, and change-control support and ensures employee engagement and compliance with EHS&S policies and programs. The position is based fully onsite in Las Piedras, Puerto Rico, and reports to the Site Quality Director.

Requirements

Bachelor of Science, preferably in Chemistry, Pharmacy, Microbiology, or Biology, or a bachelor's degree in Business Administration.
Eight or more years of experience in quality assurance, including at least four years at a supervisory level in quality assurance and/or a manufacturing environment.
Experience in areas including pharmaceutical solid and liquid dosage, OTC and controlled product manufacturing, packaging, incoming, audits, compliance, and product disposition.
Bilingual in 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, statistical process control, detection, correction and error prevention, and process system challenges.
Knowledge of sampling processes, audits, root cause analysis, and risk management.
Basic computer knowledge, including Microsoft Excel, PowerPoint, and Word.
Ability to make fact-based decisions using critical thinking and decision-making tools while meeting established deadlines and priorities.
Demonstrated leadership and organizational skills.
Knowledge of current quality assurance techniques and ability to develop and implement plans to improve quality and make decisions that drive compliant business results.
Able to travel in and outside Puerto Rico, work extra hours, respond to emergency calls after regular business hours, and support other departments or projects according to business needs.
Certifications or licenses are not required.

Responsibilities

Ensures compliance with quality systems, applicable standards, policies, procedures, processes, and specifications relating to quality and manufacturing.
Plans, coordinates, and guides review and approval of products between Downstream and Upstream stages, final disposition of bulk transfers, and finished product lots.
Supports assessment of manufacturing and packaging batch documentation and systems before assigning final product disposition.
Communicates quality metrics to QA Associates, identifies improvement areas, and implements required changes.
Manages printed material dispatch and return processes supporting packaging line operations, and environmental conditions and housekeeping in the Label Room and Reject (DO) cage.
Coordinates and supports Downstream and Upstream shop-floor activities, guiding QA and Operations teams to comply with procedures and business plans.
Reviews and approves procedures and other documents; approves master batch records, start-up protocols, and change controls as needed.
Coordinates issuance of product holds with distribution centers.
Prepares and approves protocols, supports area investigations, and develops and implements CAPAs related to QA Operations responsibilities.
Recruits, evaluates, supervises, disciplines, recognizes, develops, and rewards employees under supervision.
Develops and maintains QA Operations unit goals aligned with Quality Unit and site goals.
Ensures a cross-training program is in place to maintain workforce flexibility.
Prepares, coordinates, and documents training for new personnel; implements cross-training and development opportunities.
Identifies opportunities for new techniques, procedures, and equipment or processes to improve work efficiency.
Reviews and updates area documents, 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 headcount analysis using an activity-based model and volume forecast.
Participates in internal and external business-related committees as applicable.
Identifies the need for and writes CAPAs related to the QA Operations unit; approves investigations and CAPAs for the functional area as required.
Serves as area manager back-up, including attending meetings such as the Quality Council.
Provides support to projects and internal and external audits.
Participates in validation, protocol, and change-control design processes to ensure product hold when applicable.
Ensures compliance with and employee engagement in EHS&S policies and programs.
Travels in and outside Puerto Rico, works extra hours, responds to emergency calls requiring return to the company after regular hours, and supports other departments or projects according to business needs.