Job description
Posted:
69 days ago
Location:
New Jersey, New Jersey, United States
Job Ref:
BH-33974
Job Type:
Contract
Salary:
$20 - $26 per hour
Expiry date:
2/8/2023
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:
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.
- 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
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