The Role
Manage and store retained raw material, bulk, and finished goods samples under specified conditions; document traceability; perform visual inspections and report findings; track inventory and expirations; dispose of expired samples per regulations; and support investigations by gathering and reviewing evidence. Role requires bilingual communication and reporting.
Summary Generated by Built In
We are looking for an experienced QC Incoming Associate with experience in regulated industries.
Responsibilities:
- Managing retain samples of Raw Materials, Finished Goods and Bulk.
- Storing reserve samples under specified temperature and humidity conditions, preventing loss of integrity.
- Documenting reserve samples on logbooks and electronic systems, ensuring traceability.
- Conducting periodic visual inspection of Controlled Substances and reserve samples.
- Documenting and reporting findings from visual evaluations of customers complaints samples, detailing defect categories to aid corrective actions.
- Preparing reports regarding inventory and expiration of Controlled Substances and reserve samples.
- Identifying when reserve samples have met or exceeded their retention period and disposing them utilizing the corresponding documentation and regulatory standards.
- Contributing to investigations by gathering data and reviewing evidence.
Requirements
Skills Required
- Bachelor's degree in a scientific discipline
- At least 3 years of experience in pharmaceutical/biotech investigations
- Experience in regulated industries (pharmaceutical/biotech)
- Bilingual in Spanish and English
- Strong written and verbal communication, facilitation, and presentation skills
- Proficient in computer applications and electronic systems
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
