Senior QA Supervisor

Mcneil Ab; Puerto Rico; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Kenvue is seeking a Senior QA Supervisor to lead quality assurance operations at the Las Piedras site. You will oversee QA activities, approve change controls, CAPAs, and product dispositions, and ensure cGMP compliance.

The role involves coordinating with upstream/downstream areas and guiding QA staff. The ideal candidate has a strong background in QA leadership within pharmaceutical manufacturing, solid knowledge of GMP, and proven ability to drive quality improvements in a busy production

Qualifications

• 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 with at least four years at a supervisory level in QA/manufacturing.
• Experience with pharmaceutical solid and liquid dosage, OTC, and controlled product manufacturing, packaging, audits, compliance, and product disposition.

Responsibilities

• Recruits, evaluates, supervises, applies disciplinary actions, provides recognition, develops and rewards employees under supervision.
• Develops 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 trainings for new personnel and implements cross-training opportunities.
• Identifies opportunities for new techniques, procedures and evaluates new processes/equipment.
• Reviews and updates area, forms, protocols, and procedures to ensure cGMP compliance.
• Conducts staff meetings to communicate quality, policies, safety, business, and HR information.
• Designs, develops, and presents Quality Assurance project results and plans.
• Prepares and conducts personnel headcount analysis and volume forecast.

Skills

Quality Assurance

Supervisory experience

cGMP compliance

Documentation & audits

Education

Bachelor of Science in Chemistry/Pharmacy/Microbiology/Biology

Bachelor's degree in business administration

Job description

Kenvue is currently recruiting for a: Senior QA Supervisor

What we do

At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information , click here .

Role reports to

Site Quality Director

Location

North America, United States, Puerto Rico, Las Piedras

Work Location

Fully Onsite

What you will do

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.

• 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 coordina