PQC Associate

New Jersey, New Jersey, United States

Posted:62 days ago
Location:New Jersey, New Jersey, United States
Job Ref:BH-33974
Job Type:Contract
Salary:$20 - $26 per hour
Expiry date:2/2/2023
Xplore Life Science is recruiting for a PQC Associate. This position is responsible for handling Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance, and complaint handling is required. Maintains onsite sample room and mailroom as per departmental SOP.

Main responsibilities include:
  • Prioritizes complaints about data entry and processing.
  • Proficient with the use of all databases within the department (i.e.. ACES-Siebel, Global PTC Database, Microsoft Office).
  • Reviews and processes reconciliation with Pharmacovigilance.
  • Identifies and handles lot discrepancies correctly with returned complaint samples.
  • Performs QC Checks
  • Understands the FDA complaints regulations for the drug products and medical devices.
  • Maintains sample room and mailroom as per departmental SOP.
Candidate requirements:
  • Associate degree with experience in a pharmaceutical, administrative, and/or coordinator environment or bachelor’s degree (science discipline preferred) + years of experience in a pharmaceutical, administrative, and/or coordinator environment.
  • Area of specialization: Health or Life Sciences preferred
  • Understanding of Good Documentation Practices

Apply now