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.
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**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.
You will be responsible for:
- 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.
**Key interfaces: **
- Must be able to effectively operate in a matrixed environment and interact with cross functional local and global leaders on a regular basis.
- Complaint investigation owner(s) and cross-functional contributor (e.g., Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT).
- Other sites and affiliates (as applicable) to align investigation strategy, evidence, and outcome for site-manufactured product complaints.
- Quality leadership for escalation, risk communication, and decision alignment.
- External manufacturers/partners and laboratories (as applicable) to obtain and evaluate investigation input and analytical results.
Qualifications
Education:
- Bachelor’s degree in Life Science or related discipline (or equivalent experience) is required.
**Experience and Skills: **
- 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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
**Required Skills: **
Preferred Skills:
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)