Grifols Shared Services North America, Inc Quality Associate II / III, QC 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 II, QC / Quality Associate III, QC will perform method validations and manage implementation of test methods. He/she will guide assay performance and replacement, including test method development/validation/troubleshooting. The selected candidate will establish suitable standards and guidance for the QC test lab, and monitor global compendia and ICH validation status. The incumbent will also provide expertise and knowledge in Pharmaceutical Microbiology to aid and meet facility and departmental objectives and goals.
Coordinate, perform (hands on), or assist in the development, validation, trouble-shooting, and analytical support of equipment and test methods that support the Quality Control Microbiology, Environmental Assurance, and Sterility laboratories.
Preparation or review of assay discrepancy and conduct investigations.
Lead projects and collaborate with Production and other Quality Units (QA).
Ensure training of employees, serve as SME for laboratory assays, and act as a resource for laboratory staff.
Provide accountability and responsibility for project proposals, execution, and timely delivery.
Prepare and/or review SOP revisions, Change Control Requests, and other departmental-related documents pertaining to the main focus of responsibilities.
Demonstrate high levels of value and integrity.
Strong verbal and written communication skills
Strong problem-solving and troubleshooting skills
Strong capabilities in experimental design, execution, and data interpretation.
Hands on experience on performing biology test methods, such as: sterility, LAL, Bioburden, TOC, microbe identification and others. Hands on experience using data management systems, such as MODA, SAP, and DCM, and software associated with laboratory methods. Method validation experience preferred.
Quality Associate II, QC: BA/BS - preferably in a life science or biotechnology STEM (science, technology, engineering) curriculum and 2 yrs of relevant experience
Quality Associate III, QC: BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 3 yrs of relevant 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.
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 / Veterans/ Women/ Disabled
This position is Employee Bonus Eligible
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 82719
Type: Regular Full-Time
Job Category: Quality