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Senior Quality Associate I

1 month ago

Clayton, United States Grifols Shared Services North America, Inc Full time

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. Sr. Quality Associate I Hours: Monday throug Friday from 8 am to 3:30 pm Summary: The Senior Quality Associate I, Quality Assurance may be assigned duties and responsibilities within Quality Assurance primarily in support of filling activities, but also may include utility support. Specific duties will depend on job description and assignment, and may include; change control coordination, eview of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc. The incumbent 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. Primary responsibilities for role: ● Consults with management or use expertise to advise and influence the technical decisions of business units. ● Interacts regularly with members of management and as needed with regulatory officials. ● Participates or leads multi-disciplined project teams with highly technical objectives. ● Trains and/or may mentor employees. ● Review and approval of validations ● Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, incidents entries and investigation reports. ● Demonstrates high levels of values and integrity ● Can easily multi-task, prioritize and adapt to changing business needs. ● Preparation/review/approval of regulatory documents. ● Preparation of sections of the Annual Product Review/General Parameter APR. ● Demonstrated ability to independently make sound quality decisions with moderate guidance or on own. ● Demonstrated ability to influence decisions makers in other departments ● Review and/or approval of validations ● Other duties as assigned. In addition to the duties described above the Quality Associate may also perform the following duties based upon the business unit to which he/she is assigned: Responsibilities may include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit meetings, and project meetings. Sr. Quality Associate I BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics)discipline with minimum of 5 years relevant experience, or equivalent combination of education and 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. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws. Req ID: 516969 Type: Regular Full-Time Job Category: Quality