What are the responsibilities and job description for the Quality Complaint Investigations Specialist (Pharma/Medical Device) position at Systems Ally?
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