Grifols Shared Services North America, Inc Quality Associate II/Quality Associate III 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.

The Quality Associate provides front line data analysis and reporting for the Quality Operations Environmental Assurance Laboratories. Initiates, notifies and performs laboratory investigations for any threshold, alert or action level excursion as well as mold growth and Class A/B bacterial growth for the QO Environmental Assurance laboratory. Reviews and summarizes all environmental monitoring data relevant to the processing of each batch in an Environmental Monitoring Report. Analyze and summarizes the environmental monitoring data in a variety of reports (i.e. Annual General Parameters, Annual Product Reviews, Monthly EM report, etc.). Demonstrates strong technical expertise and ability to answer questions effectively with all levels of the organization.

Job responsibilities include:

Initiates, notifies, and/or performs laboratory investigations for any threshold, alert or action level excursion for the QO Environmental Assurance Laboratory.

Sends out daily notifications of any Mold and Class A/B bacterial growth to the Business Units at the Clayton Facility. Reviews and summarizes all environmental monitoring data relevant to the processing and release of each batch in an Environmental Monitoring Report used for product release.

Analyzes and summarizes the environmental monitoring data in a variety of reports (i.e. Weekly, Monthly, Annual General Parameters and Product Reviews, etc) and reviews specific reports with affected business units.

Submits samples to the Microbiological Identification laboratory as required.

Serves as the departments safety representative and participates on several environmental and safety committees.

Demonstrates strong technical expertise and ability to answer questions

Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

Learns and follows the requirements for Grifols' Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Performs non-routine duties, housekeeping duties, etc. as assigned.

Requirements:

QA II- MS degree in a relevant discipline (i.e. Biology, Microbiology, etc.) with minimal experience or a BA/BS degree in a relevant discipline and a minimum of 2 years of related experience, or equivalent combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements

QA III- MS degree in a relevant discipline (i.e. Biology, Microbiology, etc.) with a minimum of 2 years of related experience or a BA/BS degree in a relevant discipline and a minimum of 4 years of related experience, or equivalent combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements

Shift: Day

Salary Grade: M06/M07

Work is performed in an office and a laboratory/manufacturing environment or warehouse. 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.

EEO Minorities/Women/Disabled/Veterans

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home