Demo

Quality Complaint Investigations Specialist (Pharma/Medical Device)

Systems Ally
Skillman, NJ Full Time
POSTED ON 2/15/2025
AVAILABLE BEFORE 4/14/2025

Description:

  • The Analyst triages, evaluates and determines if investigation is necessary for product quality complaints and adverse events for the Self-Care product portfolio of Client Consumer products in accordance with Standard Operating Procedures using the Product Quality Management System.
  • This may include but is not limited to review of complaint case to verify customer verbatim, lot number, subject coding, malfunction coding, trend analysis, assignment of complaint to investigation team.
  • The Analyst investigates product quality complaints, review of manufacturing and packaging investigations, complaint summary, complaint closure and escalation.
  • Performs field sample management process for products returned from Consumer.
  • Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
  • Assists with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents.
  • As necessary, this position will support the Triage, Investigation, and field sample function in other Geographical regions for Consumer products.
  • The Analyst must have the ability to assist with/participate in various projects within the department, communicate effectively with management.
  • This role will analyze data and other trends.
  • Will prepare and present Complaint Vigilance data to QA Management and cross functional business partners.
  • This role reports to the Manager, Self-Care Complaint Vigilance.
  • Participates directly or indirectly on regional and global complaint vigilance initiatives, and project teams to develop, consolidate, and/or improve complaint vigilance and related/interfacing processes.

Job Type: Contract

Pay: $42.00 - $44.00 per hour

Expected hours: 40 per week

Benefits:

  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Education:

  • Bachelor's (Preferred)

Experience:

  • complaint investigation: 5 years (Preferred)
  • investigates product quality complaints,: 5 years (Preferred)
  • prepare and present Complaint Vigilance data: 5 years (Preferred)
  • review of manufacturing and packaging investigations: 4 years (Preferred)
  • review of complaint case to verify customer verbatim: 5 years (Preferred)
  • pharma or medical device industry: 5 years (Preferred)

Ability to Commute:

  • Skillman, NJ 08558 (Required)

Work Location: In person

Salary : $42 - $44

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