QA Investigations Specialist III

Summary

Quality Assurance Investigation Specialist IIIJohnson & Johnson is currently seeking two Quality Assurance Investigation Specialist III to join our QA team located in Raritan, NJ!At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.In this role, the Sr. Quality Specialist leads robustness of NC/CAPA investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive. This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation and CAPA owners, resolve collaborator conflicts, and escalate issues to senior management when required.Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!Main Responsibilities will include, but are not limited to:Complete quality reviewer/approver duties, review evidence, and approve closure of NC and CAPA records.Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures.Provide coaching and actionable feedback to issue owners on CAPA standard methodologies, system usage, and investigation execution.Collaborate with team members to support the end-to-end NC/CAPA process.Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level.Use data analytics and trending to identify failure modes, measure CAPA effectiveness, and inform continuous improvement priorities.Compile and provide regular CAPA status updates, metric reports, and trending analyses.Collaborate with collaborators, site owners, governance bodies, and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues as needed.Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests.Participate in and/or support internal audits and regulatory inspections, as needed.Attend, participate and/or facilitate SC NC CAPA review meetings, as needed.Perform other duties as necessary.QualificationsEducation:Bachelor's Degree in Life Science or related field or equivalent is required.Skills & Experience:Knowledge and experience with regulations and regulatory compliance issues.Minimum of 6 years' experience in a regulated field and/or equivalent experience/training in an investigations' capacity.Demonstrated experience in an investigation related function.Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.Requires critical analytical and problem-solving skills, strategic problem solver, and collaborator.Excellent organization, prioritization, and time management skills.Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.Other core skills: strong attention to detail, excellent time management, relationship-building, and experience with CAPA systems, investigative techniques, and data-driven quality improvement.Other:Requires ability and flexibility to work 8-hour shifts 1st shift Monday - Friday, and provide occasional off shift or weekend support, as needed.This position is located primarily in Raritan, NJ, and may require up to 5% local travel.The anticipated base pay range for this position is $94,000.00 - $170,000.00 USD annual.Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Job Description

Quality Assurance Investigation Specialist IIIJohnson & Johnson is currently seeking two Quality Assurance Investigation Specialist III to join our QA team located in Raritan, NJ!At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.In this role, the Sr. Quality Specialist leads robustness of NC/CAPA investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive. This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation and CAPA owners, resolve collaborator conflicts, and escalate issues to senior management when required.Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!Main Responsibilities will include, but are not limited to:Complete quality reviewer/approver duties, review evidence, and approve closure of NC and CAPA records.Conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures.Provide coaching and actionable feedback to issue owners on CAPA standard methodologies, system usage, and investigation execution.Collaborate with team members to support the end-to-end NC/CAPA process.Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level.Use data analytics and trending to identify failure modes, measure CAPA effectiveness, and inform continuous improvement priorities.Compile and provide regular CAPA status updates, metric reports, and trending analyses.Collaborate with collaborators, site owners, governance bodies, and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues as needed.Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests.Participate in and/or support internal audits and regulatory inspections, as needed.Attend, participate and/or facilitate SC NC CAPA review meetings, as needed.Perform other duties as necessary.QualificationsEducation:Bachelor's Degree in Life Science or related field or equivalent is required.Skills & Experience:Knowledge and experience with regulations and regulatory compliance issues.Minimum of 6 years' experience in a regulated field and/or equivalent experience/training in an investigations' capacity.Demonstrated experience in an investigation related function.Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.Requires critical analytical and problem-solving skills, strategic problem solver, and collaborator.Excellent organization, prioritization, and time management skills.Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.Other core skills: strong attention to detail, excellent time management, relationship-building, and experience with CAPA systems, investigative techniques, and data-driven quality improvement.Other:Requires ability and flexibility to work 8-hour shifts 1st shift Monday - Friday, and provide occasional off shift or weekend support, as needed.This position is located primarily in Raritan, NJ, and may require up to 5% local travel.The anticipated base pay range for this position is $94,000.00 - $170,000.00 USD annual.Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.