PQC Associate

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