Complaint Quality Approver

2162-Janssen Ortho Legal Entity•Gurabo, PR

4d•Onsite

About The Position

Johnson & Johnson is seeking a Complaint Quality Approver for its site in Gurabo, Puerto Rico. The role independently and objectively reviews and approves complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations. The approver confirms 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 role covering complaint records owned by the site, including complaints received from other company affiliates for products manufactured at the site. The approver helps align investigation strategy and outcomes across functions and sites, as applicable. The role works with investigation owners, cross-functional contributors, other sites and affiliates, Quality leadership, and external manufacturers, partners, and laboratories when needed.

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 with quality systems and 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; 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 under global and site procedures.
Clear, concise writing skills, including the ability to provide precise approval rationale and actionable feedback.
Demonstrated ability to provide professional, actionable feedback.
Critical thinking, problem-solving, and decision-making skills.
Strong organization, prioritization, and time-management skills, including the ability to meet deadlines and manage multiple records.
Analytical skills, including the ability to interpret trends and performance metrics.
Ability to work independently and as part of a team.
Ability to operate effectively in a matrixed environment and interact with cross-functional local and global leaders.

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 closure.
Confirm alignment on investigation strategy and the appropriateness of root cause analysis.
Ensure appropriate investigation tools are used and relevant stakeholders are involved, including consideration of end-to-end supply chain factors when applicable.
Review investigation updates, request clarification or additional evidence, and ensure new information and follow-up narratives are accurately incorporated into the PQMS record, including any actions required.
Confirm risks are identified, managed, and escalated, and support actions as needed.
Verify data integrity and ensure conclusions, including root cause, 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 issue owners with coaching and actionable feedback 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 with cross-functional local and global leaders in a matrixed environment.
Coordinate with complaint investigation owners and contributors from functions such as Manufacturing, QC, Engineering, Supply Chain, Packaging, and MSAT.
Align investigation strategy, evidence, and outcomes with other sites and affiliates as applicable.
Escalate risks and communicate with Quality leadership to support decision alignment.
Obtain and evaluate investigation input and analytical results from external manufacturers, partners, and laboratories as applicable.