Grifols Shared Services North America, Inc Principal Quality Associate/Sr. Quality Associate II 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.
Sr. Quality Associate II
The incumbent will serve as the SME for Fraction II product lines (10% IGIV-C, 20% IGSC, IGCP, IGIMs). In this role the incumbent will interface with plant manufacturing and support groups to execute site quality systems. The incumbent will advise and make technical decisions in relation to product quality based on his/her knowledge of product testing and processes. He/she may coordinate and lead more complex investigations as well as implementation of appropriate corrective/preventative actions. The incumbent may support compliance initiatives including auditing of manufacturing and other areas. Responsibilities include review and approval of change controls, test plans, Regulatory documents, validation and stability documentation, directing annual product reviews, maintaining Design History Files, and tracking and trending information/data. Other responsibilities may include providing Quality input for Validation projects, capital engineering projects, new development products, clinical studies, stability studies, Regulatory submissions and laboratory support projects, lead/participate in CIP project teams. The incumbent acts as a functional manager and is expected to be able to independently make decisions. He/she will be expected to represent the Quality Manager at business unit and project meetings as needed.
Requires a PhD in Life Sciences with minimum of 4 years relevant experience; MS in Life Sciences with minimum of 6 years relevant experience; or a BS in Life Sciences with minimum of 8 years relevant experience.
The position requires a strong knowledge of cGMPs, a proactive philosophy; attention to detail; excellent judgement, investigative, analytical, and organizational skills; the ability to solve complex technical problems and good human interaction skills as demonstrated in previous work.
The Incumbent must be able to work independently or as part of a team as required by the situation at hand. He/she should be able to lead teams and to promote a team approach
The incumbent must be able to recognize trends, prepare reports/presentations and be able to effectively communicate information to varying levels of management.
The Incumbent must be a professional with high technical competency who is recognized as an authority in multiple areas.
Desired computer skills include MS Office (Excel, Word, and Power Point), Trackwise, Moda, Meridian, Maximo and SAP. Knowledge of Fraction II Products is desired. Experience in different aspects of the pharmaceutical business (manufacturing, laboratory testing, validation, research, etc.) is a plus.
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. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
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.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 77443
Type: Regular Full-Time
Job Category: Quality