Job Description

JOB OBJECTIVE

Quality Assurance (QA) Inspectors work with PLC operations during the production process, by approving the raw materials and associated documentation for incoming plasma shipments from donor centers (DC), in-process production batches (Production Units - PUs), and the final Plasma Lot shipment for distribution and sales at the Grifols Plasma Logistics Center (GPLC).

QA Inspectors identifies and document deviations of both materials and the manufacturing process and ensure these deviations are corrected to ensure a better finished product for prospective customers.

ENVIRONMENT

Internal: PLC Operations, Look Back Specialist, Manufacturing Facility.

External: Auditors

KEY RESPONSIBILITIES

• Approves incoming plasma shipment documentation and raw materials by confirming specifications, rejects and returns unacceptable materials as directed by QA Supervisor.
• Monitors the quality of the production operation by constantly auditing the production process to ensure compliance with customer specifications and GPLC standard operating procedures.
• Generates and documents non-conformance of plasma units rejected from plasma shipments, in process batches or final plasma Lots.
• Approves in-process plasma batches (PU's) and final plasma lot shipments by confirming customer and regulatory specifications and communicating required adjustments to the QA Supervisor.
• Responsible for inspecting final outgoing plasma lot shipments to ensure all pallets are properly packaged and loaded for sales and distribution.
• Investigates and reports in-process/final plasma lot and processes that do not meet quality specifications and document in a deviation report.
• Participates in the writing or revision of policies and standard operating procedures related to Source Plasma and quality systems at Plasma Warehouse level.
• Documents approval activities in the organizations computer system (Plasma Logistic System- PLS) to maintain accurate records.
  
  

ACADEMIC EXPERIENCE REQUIRED

Bachelors Degree in Health-related Sciences.

Knowledge in quality Management.

Strong integrity and commitment to quality and compliance.

PROFESSIONAL EXPERIENCE REQUIRE

• Typically requires a minimum of 2 years of related experience.
• Preferred Pharma background.

COMPUTING SKILLS

Proficiency with computers.

PERSONAL SKILLS

Organized and able to manage time effectively.
Ability to work within a highly regulated, labor intensive environment.
Ability to understand, explain, follow, and enforce SOPs and protocols.
Ability to plan, communicate and execute activities for the improvement of overall operations.

LANGUAGES
Written and spoken English and Arabic.