Job Function:

Quality Job Sub Function:

Customer/Commercial Quality Job Category:

Professional All Job Posting Locations:

Horsham, Pennsylvania, United States of America Job Description:

Johnson & Johnson is currently recruiting for a Complaint Operations Specialist- Outreach & Field Sample Management! This position will be located in Horsham, PA.

Position Summary:

The Complaint Operations Specialist - Outreach & Field Sample Management is responsible for executing timely, compliant, and well-documented complaint outreach and field sample retrieval activities in support of Product Quality Vigilance. The role will serve as a key operational owner for field sample coordination, including patient or customer outreach, field sample retrieval kit dispatch, follow-up activities, sample receipt coordination, and transfer of samples to the appropriate investigation site or designee. The Specialist will help sustain compliance, reduce delays, and support continuous improvement across the end-to-end field sample retrieval process.

Key Responsibilities:

Perform field sample outreach by contacting complainants via phone or written communication, while ensuring activities are completed within required timelines and documented in accordance with applicable procedures. Initiate and clearly document outreach and field sample retrieval attempts in the complaint handling system. Send field sample retrieval kits, prepaid mailers, instructions, labels, and related materials to patients, customers, or local operating companies as appropriate. Monitor global field sample dashboards daily to ensure compliance to procedures in a timely manner Coordinate receipt, processing, tracking, and shipment of returned field samples to the appropriate investigation site, J&J location, or approved designee. Support documentation of shipping, trade compliance, tracking information, sample status, and related evidence within applicable systems and records. Communicate with internal partners, local operating companies, investigation sites, and other stakeholders to resolve field sample retrieval questions, delays, or documentation gaps. Ensure outreach and field sample retrieval activities are completed with appropriate attention to patient/customer interaction, data quality, and complaint record completeness. Support process improvements, standardization efforts, monitoring enhancements, and training updates related to outreach and field sample management.

Qualifications:

Education:

Associate degree or equivalent relevant experience required; bachelor's degree preferred.

Required:

Associate degree or equivalent relevant experience required; bachelor's degree preferred. Experience working in a regulated, quality, healthcare, pharmaceutical, medical device, or GxP environment. Strong written and verbal communication skills, including ability to interact professionally with internal partners and external patients or customers. Demonstrated ability to follow procedures, meet timelines, and accurately document activities in business or quality systems. Strong attention to detail and commitment to documentation accuracy, data quality, and compliance. Intermediate computer skills, including experience with Microsoft Office tools and ability to learn complaint handling or quality management systems. Ability to work in a fast-paced environment, prioritize daily workload, and adapt to changing process requirements. Ability to work on site to support field sample kit dispatch, sample receipt, sample handling, and shipment coordination.

Preferred:

Prior experience supporting product quality complaints, complaint outreach, field sample retrieval, or sample logistics. Experience documenting tasks in a GxP system or complaint handling system. Knowledge of good documentation practices, quality system requirements, and complaint management principles. Experience with shipping coordination, trade compliance documentation, tracking numbers, sample handling, or investigation site coordination. Demonstrated ability to identify process gaps and recommend practical improvements to strengthen compliance and execution. 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.

Required Skills:

Preferred Skills:

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