Principal Quality Associate, QA Filling

GRIFOLS, S.A.•Clayton, NC

7d•Onsite

About The Position

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. The Principal Quality Associate, Quality Assurance Filling Business Unit, may be assigned duties and responsibilities within Quality Assurance supporting Filling. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, product/raw material sampling and/or testing, sampling/testing/data analysis of environmental monitoring samples and data, auditing, data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. Can make quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. Can identify continuous improvement opportunities and drive the change and assess impact to other areas of the business. 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. Serves as delegate to the manager. In addition to the duties described above the Principal Quality Associate, Quality Assurance may also perform the following duties: 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 manager at business unit meetings, and project meetings. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Requirements

M10: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BS/BA is required.
Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be able to work independently.

Responsibilities

Use expertise to advise and influence the technical decisions of business units.
Responsible for development, maintenance and vitality of essential Grifols technologies.
Interacts regularly with members of management and as needed with regulatory officials.
Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion.
May mentor employees.
Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System 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 as well as the overall APR
Demonstrated ability to independently make sound quality decisions
Demonstrated ability to influence decisions makers in other departments
Review and approval of validations
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.