QA Operations Associate III (Second Shift)

Kenvue•Las Piedras, PR

1d•Onsite

About The Position

Kenvue is currently recruiting for a: QA Operations Associate III (Second Shift) 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: Quality Assurance Supervisor The QA Operations Associate III identifies, notifies and supports Operations and Quality management in the timely resolution of Shop Floor situations maintaining the highest level of compliance with cGMPs and company standards and procedures. Provides daily quality support to the Manufacturing and Packaging floor consistent with the Supply Chain's goals while meeting Quality and Compliance goals. Executes online quality review of electronic batch records (e-BRs) and pursues issues’ resolutions. Supports the review of any GMP documentation supporting the Operations and the final product disposition stage. Responsible for the Label Room printed material dispatch and returns to the Packaging lines, the monitoring of the environmental storage conditions and maintenance of the Label Room area. Generates and reviews area investigations and applicable CAPAs. Assigns final disposition to products between stages, bulk transfers and finished products. Serves as a back-up to support the disposition of raw materials and packaging components and the review and approval of work orders. This role is requested for the Second Shift - 2:00pm to 10:30pm

Requirements

Bachelor’s degree in Chemistry, Pharmacy, Microbiology, Biology, or Engineering.
6–8 years in QA within pharmaceutical, OTC, or controlled product manufacturing.
Bilingual in English and Spanish (verbal and technical writing).
Strong understanding of cGMPs, batch record review, and compliance.
Proficient in SAP inventory transactions and Microsoft Office.
Skilled in investigations, root cause analysis, statistical sampling, and risk management.
Strong analytical, decision‑making, and communication skills.
Ability to work independently, under pressure, and meet deadlines.
Ability to travel locally and internationally.
Availability for overtime and emergency call-backs.
Willingness to support cross-functional projects as needed.

Responsibilities

Ensure adherence to cGMP, SOPs, and all regulatory requirements.
Complete required training prior to task execution.
Identify, report, and help resolve deviations promptly.
Demonstrate integrity, accountability, and Right‑First‑Time (RFT) behaviors.
Support internal and external audits as needed.
Comply with all EHS policies, procedures, and ISO 14001 requirements.
Promote a safe work environment, proper PPE use, and reporting of incidents/near misses.
Participate in waste reduction, energy-saving initiatives, ergonomic programs, and safety monitoring.
Ensure procedural compliance in manufacturing and packaging areas.
Perform packaging line clearances and document findings.
Review electronic batch records, documentation, and supporting records for final disposition.
Provide on‑the‑spot cGMP guidance and support for shop‑floor decision-making.
Execute inventory status changes in SAP and manage label room operations.
Contribute to investigations, CAPA follow-up, and quality improvements.
Participate in projects and represent the Quality Unit when assigned.
Interact with regulatory agencies, primarily in English.
Review and approve batch records to assign usage decisions.
Execute disposition of in‑process stages, bulk transfers, and finished goods.
Serve as back‑up for raw material/component disposition and QA supervisory tasks.
Initiate and conduct investigations related to quality events.