Sr. Quality Associate II/ Principle Quality Associate

Sr. Quality Associate II/ Principle Quality Associate

Location: NC-Clayton, US Contract Type: Regular Full-Time Area: TECHNICAL

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Shift: Day – Monday through Friday 8:00am-5:00pm

Sr. Quality Associate II/ Principle Quality Associate:

The successful candidate must have a strong knowledge of cGMPs, the ability to perform independently, and the ability to solve moderate to complex technical problems. A broad knowledge of Quality processes is preferred. A proactive philosophy, attention to detail, and good human interaction skills are essential and must have been demonstrated in previous work. The candidate should be able to analyze data and recognize trends, prepare reports/presentations and be able to effectively communicate information to varying levels of management both verbally and in written forms. He/she should be able to lead teams of varying complexity and to promote a team approach. The successful candidate must be a professional with moderate to high technical competency who is recognized as a SME/authority in multiple areas. The successful candidate must demonstrate good to excellent judgement, and investigative, analytical, and organizational skills. Additional desired computer skills include Excel, Word and PowerPoint. Priority will be given to those candidates who demonstrate extensive knowledge of Quality systems and tasks including the CCR process, CAPAs, SAP, DCM, incident coordination and resolution. Knowledge of the Alpha process or demonstrated support is also highly desired but not required.

Sr. Quality Associate II : The successful candidate is an established and technically competent professional who develops and implements solutions to a variety of quality related objectives. He/she may participate on teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium/ high complexity, developing solutions for defined problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

Principle Quality Associate : The successful candidate is a professional with high technical competency who leads projects or discipline teams. The employee influences the direction of complex projects and communicates with all levels of employees. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

The primary responsibilities for this position will be: to support all aspects of the Alpha-1 product line including production processes and process changes, clinical support, and all Quality aspects for the B300 Zone 2 business unit (CCRs, CAPAs, and incidents) interface with site Manufacturing, Compliance, Regulatory, and other groups from across the Grifols organization to support defined projects Preparation of relevant annual product reviews including product quality reports for the EU SOP review and revision for the functional areas supported compliance initiatives including auditing of Purification and other areas as required in addition to interacting with authorities during inspections multi-disciplined project teams to resolve site/ global Quality issues clinical, stability, and engineering projects as required Quality management and site KPIs.

Requirements: Sr. Quality Associate II : Requires a BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 3 years relevant experience, or equivalent combination of education and experience. Principle Quality Associate : Requires a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience. Work is performed in an office and a manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms is possible. Exposure to occasional cold (2-5 ° C) in production areas is also possible. Personal protective equipment such as protective eyewear, garments and gloves is required and provided. Work is performed sitting or standing for 2-8 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. 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.