Grifols Shared Services North America, Inc Quality Assurance Inspector in Clayton, North Carolina
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
SHIFT: 5:30 am - 2:00 pm / Monday - Friday
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 Grifols Plasma Logistics Center (GPLC). 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.
Primary responsibilities include but are not limited to:
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 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 GPLC.
Executes repetitive 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.Requirements:
High School diploma or GED in addition to 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 preferred.
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.
Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
Learn more about Grifols at http://www.grifols.com/es/web/international/home