Sr QA Specialist IMSC NC CAPA

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Horsham Pennsylvania United States of America Raritan New Jersey United States of America

Job Description:

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 are searching for the best talent for Sr QA Specialist IMSC NC CAPA to be in

Raritan New Jersey and Horsham Pennsylvania

• Support efficient and effective investigation training/certification. Support NC/CAPA system and process user training

• Facilitate the initiation of investigations and CAPAs and monitor progress and approvals.

• Collaborate with key stakeholders to support the end-to-end NC/CAPA process.

• Support NC/CAPA system and process user training including investigation certification.

• Facilitate initiation of investigations and CAPAs and monitor progress to ensure timely completion.

• Execute 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.

• 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 stakeholders site owners governance bodies and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues to the Senior Manager Quality Systems CAPA as needed.

• Coordinate with IMSC sites and responsible functions to drive completion of assigned actions.

• Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests.

• Ensure the IMSC NC/CAPA process remains inspection-ready and support audits/inspections.

• Provide coaching and actionable feedback to issue owners on CAPA best practices system usage and investigation execution.

• 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.

Qualifications and Requirements:

• Bachelors Degree in Life Science or related discipline or equivalent is required.

• Knowledge and experience with regulations and regulatory compliance issues.

• Minimum of 6 years experience in a regulated MedTech or Pharmaceutical Quality Systems Compliance field

• and/or equivalent experience/training in a related NC CAPA Investigation Quality System area.

• Demonstrated experience as an investigator of Non-Conformance/CAPA process.

• Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.

• Requires critical analytical and problem-solving skills strategic thinker 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. Ability to build and maintain cross-functional interactions and coordination. Ability to build consensus influence and negotiate.

• Knowledge of Quality Management Project Management and/or Process Excellence concepts and practices.

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 Internal employees contact AskGS to be directed to your accommodation resource.

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)

The anticipated base pay range for this position is :

94000.00 - 151800.00

Additional Description for Pay Transparency:

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: o Vacation up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year o Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. Experience:

Senior IC