QC Incoming Inspector

Purpose

The Quality Incoming Inspector is responsible for the sampling, inspection, and approval of packaging components, as well as the testing of both packaging components and some raw materials. Ensure compliance with all quality control policies, procedures, and systems to facilitate the timely release of high-quality products that support the supply chain process.

Responsibilities

• Performs sampling, inspection, testing, and approval of packaging components in accordance with internal and external regulations and policies, ensuring compliance with supply chain approval cycle time goals.
• Performs sampling and testing of raw materials in accordance with internal and external regulations and policies, ensuring compliance with supply chain cycle time goals.
• Inspects labeling, quantity, and materials or products to be shipped.
• Maintains the Retention Room in an organized manner.
• Audits the Certificate of Analysis and Certificate of Compliance Receiving Report for raw materials and packaging components.
• Maintains accurate and orderly records of all work performed and collaborates with the Technical Development group during product validation activities and the transfer of new products.
• Assigns appropriate disposition to materials/products through the Computer System within established cycle time and schedules.
• Verifies (Peer Reviewer) data/results generated by another Incoming Inspector.
• Maintains and controls documents in safe files, ensuring the protection of active records.
• Acts as an OMP ISO 14001 Team Member, supporting the Environmental Management System Coordinator in implementation, training, and continuous improvement of the EMS.
• Conducts monthly environmental audits in their operational area.
• Provides environmental talks on a bi-monthly basis to their operational area.
• Conducts weekly inspections of chemical cabinets in their operational area.
• Provides assistance in conducting semi-annual Environmental Management System audits at the JSC-Gurabo site.

Qualifications / Requirements

• Bachelor's Degree in Natural Science, preferably with a major in Biology or Chemistry, and 0-2 years of experience in a pharmaceutical GMP environment; or
• Associate's Degree in Natural Science and 2-4 years of experience in a pharmaceutical GMP environment; or
• High School Diploma and a minimum of 4 years of experience in a pharmaceutical GMP environment.
• Knowledge of cGMPs and safety regulations.
• Fluent in both Spanish and English.
• Basic computer, software knowledge, and word processing.
• Knowledge use ANSI Inspectors Rule.
• Knowledge of Product & Body function is preferred.
• Availability to work 1st, 2nd, 3rd, and 12-hour shifts, including overtime, weekends, and holidays.