Grifols Shared Services North America, Inc Sr. Quality Associate I 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.
Sr. Quality Associate I
The incumbent will serve as the SME for a product line such as Alpha MP/Liquid Alpha. 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 assays and processes. He/she may coordinate and lead more complex investigations and implementation of corrective and preventative actions. The incumbent may support compliance initiatives including auditing of Purification and other areas. Other responsibilities may include providing Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsibilities include approval of change controls, test plans and regulatory documents; review of validation and stability documentation, directing annual product reviews, maintaining design history files, and tracking and trending information. He/she will lead and/or participate in CIP and project teams. The incumbent acts as a functional manager and is expected to be able to independently make decisions. He/she will be responsible for representing the Quality manager at business unit and project meetings.
Requires a PHD in Life Sciences with minimum of 2 years relevant experience; MS in Life Sciences with minimum of 4 years relevant experience; or a BS in Life Sciences with minimum of 6 years relevant experience.
The incumbent must have a strong knowledge of cGMPs, the ability to perform independently, and the ability to solve complex technical problems. A broad knowledge of assays and processes is required. A proactive philosophy, attention to detail, and good human interaction skills are essential and must have been demonstrated in previous work. The incumbent must be able to recognize trends, prepare reports/presentations and be able to effectively communicate information to varying levels of management. He/she should be able to lead teams and to promote a team approach. Incumbent must be a professional with high technical competency who is recognized as an authority in multiple areas. Incumbent must have excellent judgement, and investigative, analytical, and organizational skills. Desired computer skills include Excel, Word and SAP. Experience in different aspects of pharmaceutical business is a plus.
Shift: Day – Monday through Friday 8:00am-5:00pm
Salary Grade: M08
Hiring Manager: Jennifer Guy
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: 71347
Type: Regular Full-Time
Job Category: Quality