Grifols Shared Services North America, Inc Quality Assurance Inspector in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Shift: 1st Shift; Tuesday - Saturday
Quality Assurance Inspectors work with manufacturing operations during the production process, by approving the raw materials and associated documentation for incoming plasma shipments from donor collection centers, in-process production batches (Production Units - PUs), and the final plasma Lot shipment for distribution and sales at the Plasma Logistics Center (GPLCE). Quality Assurance 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.
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 GPLCE 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 (Pus) 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 product 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 GPLCE.
Executes repetitve functions with strict adherence to procedures and maintains record accountability
Documents approval activities in the organizations computer system (Plasma Management System- SGP) to maintain accurate records
Expereince and Education
High School diploma or GED.
Typically requires a minimum of 1 year of Quality Assurance related experience and 2 years working in pharmaceuticals. Experience in the pharmaceutical, plasma/blood banking or medical device industry is ideal and working knowledge of cGMP helpful.
Good communication skills with the ability to express ideas with clarity and thoroughness in both verbal and written communications. Proactive, results oriented with a strong attention to detail. Strong interpersonal skills to interface with manufacturing operators and various levels of management as well as with support and service departments. Ability to work in a team-oriented enviroment and follow safety guidelines. Must be computer literate with experience in the use of Microsoft applications. Able to perform basic arithmetic functions including addition, subtraction, multiplication, division and using decimals.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 76727
Type: Regular Full-Time
Job Category: Quality