Johnson & Johnson Consumer Inc., a member of Johnson &
Johnson's Family of Companies, is recruiting for an Analyst III, Complaint
Vigilance to be based in Skillman, NJ
Johnson & Johnson Family of Companies touches more than a
billion people’s lives each day through our health care products and services,
our corporate giving, and the volunteer efforts of our employees. The Johnson
& Johnson Group of Consumer Companies develop and market beloved brands
that address the needs of consumers and health care professionals worldwide.
Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care,
Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The Analyst III, Complaint Vigilance will:
- Evaluate adverse events and product quality complaints and
processes cases in accordance with Standard Operating Procedures using the
Product Quality Management System.
- This may include, but is not limited to, reviewing complaint case
to verify customer verbatim, lot number, subject coding, trend analysis,
malfunction coding, and complaint closure as applicable, and escalation, as
- Collaborate with External Manufacturing Sites, Internal
Manufacturing Sites, External Manufacturing QA, Business Quality, Medical
Safety, R&D and other business partners to ensure the integrity,
consistency, compliance, and alignment of the end-to-end complaint vigilance
- Assist with developing training presentations for complaint
vigilance process and systems and creation and updates of controlled documents.
- Assist with various projects within the department, and
communicate effectively with all levels of management.
- Analyze data and perform periodic complaint trend analysis.
- Will prepare and present Complaint Vigilance data to QA Management
and cross functional business partners.
- Process serious product complaints according to internal Standard
- Perform complaint case review, trend analysis, return sample
evaluation, malfunction coding, as applicable, investigation by manufacturing
site and escalation, as appropriate.
- Ensure all relevant data for complaints are obtained and well
documented in accordance with closure timelines.
- Complete periodic product complaint trend analysis, Complaint
Vigilance reports and presentations per established procedures.
- Prepare and issue meeting minutes, ensure action items are
- Monitor Complaint Records in PQMS to ensure standard process is
being followed and complaints are closed as required, and will prepare reports
- Support internal and external audits and may participate as
Subject Matter Expert as needed.
- A minimum of a Bachelor’s degree (or equivalent degree) is
- A degree focused in Science, Engineering or related field is
- A minimum of 5 years of
related experience, including Quality Assurance and/or Quality Control, in a highly
regulated environment is required.
- Experience working in an FDA regulated environment is required.
- Experience supporting many/all aspects of the complaint vigilance
life cycle for pharmaceutical, medical device, and /or cosmetic/OTC products is
- Complaints Vigilance experience focused in Medical Device and/or Pharmaceutical
is strongly preferred.
- Strong knowledge of GMP
regulations is required.
- Experience with PQMS or similar
Complaint Management system is preferred.
- Experience supporting manufacturing, packaging, and development
operations is preferred.
position will be based out of Skillman, NJ and may require up to 10%
travel depending on business needs.
United States-New Jersey-SkillmanOrganization
J & J Consumer Inc. (6101)Job Function