Complaint Quality Approver

Johnson & Johnson Innovative Medicine•Gurabo, PR

5d•Onsite

About The Position

The Complaint Quality Approver independently and objectively reviews and approves complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations. The role verifies that risks are assessed, root causes and actions are supported by evidence, required stakeholders are involved, and records can be closed with clear, consistent outcomes. This is a site-based position focused on complaint records owned by the Gurabo site, including complaints received from company affiliates for products manufactured there. The approver aligns investigation strategy and outcomes across functions and sites, as applicable, and supports investigation owners throughout the complaint lifecycle.

Requirements

Bachelor’s degree in Life Science or a related discipline, or equivalent experience.
At least 4 years of experience performing and/or reviewing quality investigations, such as complaints, deviations, nonconformances, or similar quality events.
Experience working within quality systems and with applicable regulatory and compliance requirements.
Knowledge of complaint handling, investigations, and corrective and preventive action concepts in a regulated environment.
Understanding of cGMP, Good Documentation Practices, and applicable regulations, including familiarity with U.S. and international GMP expectations for pharmaceuticals or medical products as applicable to the site.
Ability to review technical data and documents, such as batch records, test results, protocols, and 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, including the ability to write concise documentation and provide precise approval rationale and actionable feedback.
Proven critical-thinking, problem-solving, and decision-making skills.
Analytical skills, including the ability to interpret trends and performance metrics.
Strong organization, prioritization, and time-management skills, including the ability to meet deadlines and manage multiple records.
Ability to work independently and in teams.

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 provide final Quality approval before record closure.
Confirm alignment on investigation strategy and the appropriateness of Root Cause Analysis (RCA).
Ensure appropriate investigation tools are used and relevant stakeholders are involved, including consideration of end-to-end supply chain factors.
Support investigation owners by reviewing updates, requesting clarification or additional evidence, and ensuring new information and follow-up narratives are accurately incorporated into the complaint (PQMS) record.
Confirm risks are identified, managed, and escalated, and support actions as required.
Verify data integrity and ensure conclusions, including RCA, are supported by objective evidence.
Confirm trending and recurrence considerations are addressed and that investigation summaries and outcomes are clear and aligned across sites or affiliates when applicable.
Provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution.
Verify required actions, including nonconformance actions when applicable, are defined, owned, and appropriately tracked before approving complaint records.
Interact effectively with cross-functional local and global leaders, investigation owners, contributors, other sites and affiliates, Quality leadership, and external manufacturers, partners, and laboratories as applicable.