Complaint Quality Approver (2 openings)

Johnson & Johnson Innovative Medicine • Gurabo, PR

5d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Gurabo, Puerto Rico, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Complaint Quality Approver (2 openings) to be located in Gurabo, PR. The Complaint Quality Approver is accountable for independent, objective review and approval of complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations. The role confirms that risk is assessed, root cause and actions are adequately supported by evidence, required stakeholders are involved, and the complaint record can be closed with a clear and consistent outcome. This is a site-based role applicable to the approver of complaint records owned by the site, including complaints received from other company affiliates for products manufactured at the site, and ensures alignment on investigation strategy and outcome across functions and sites as applicable.

Requirements

• Bachelor’s degree in Life Science or related discipline (or equivalent experience) is required.
• Minimum of 4 years of experience performing and/or reviewing quality investigations (complaints, deviations, nonconformances, or similar quality events).
• Experience working within quality systems and with applicable regulatory and compliance requirements.
• Demonstrated ability to write clear, concise documentation and provide professional, actionable feedback.
• Proven critical thinking, problem-solving, and decision-making skills.
• Strong organization, prioritization, and time management skills.
• Knowledge of complaint handling, investigations, and corrective and preventive action concepts in a regulated environment.
• Understanding of cGMP, Good Documentation Practices, and applicable regulations; familiarity with U.S. and international GMP expectations for pharmaceuticals/medical products (as applicable to the site).
• Strong ability to review technical data and documents (e.g., batch records, test results, protocols, procedures) and identify gaps or inconsistencies.
• Ability to assess whether conclusions (including root cause) are supported by objective evidence.
• Ability to evaluate risk and ensure appropriate escalation and actions according to global and site procedures.
• Clear written communication skills to provide precise approval rationale and actionable feedback.
• Analytical skills, including ability to interpret trends and performance metrics.
• Ability to work independently and in teams; strong organization skills to meet deadlines and manage multiple records.

Nice To Haves

• Business Alignment
• Business Savvy
• Coaching
• Communication
• Compliance Management
• Continuous Improvement
• Fact-Based Decision Making
• Human-Centered Design
• ISO 9001
• Issue Escalation
• Problem Solving
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment
• Standard Operating Procedure (SOP)

Responsibilities

• Review complaint records throughout the investigation lifecycle and provides the final Quality approval before record closure.
• Confirms alignment on investigation strategy, Root Cause Analysis (RCA) is appropriate.
• Ensure the appropriate investigation tools are used, and that the right stakeholders are involved, including consideration of end-to-end supply chain factors as applicable.
• During execution, supports the investigation owner by reviewing updates, requesting clarification or additional evidence, and ensuring new information and follow-up narratives are accurately integrated into the complaint (PQMS) record, including any actions required based on new information.
• Confirms risks are identified, managed and escalated, and supports actions as required.
• Prior to approval, the approver verifies data integrity and that conclusions (including RCA) are supported by objective evidence, confirms trending and recurrence considerations are addressed, and ensures the investigation summary and outcome are clear and aligned across sites/affiliates when applicable.
• Provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution.
• Verifies required actions (including NC, when applicable) are defined, owned, and appropriately tracked before approving the complaint record.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level