Quality Associate II

Grifols SA•Clayton, NC

44d

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. Shift: Day Quality Associate II/III The Quality Associate II/III will be assigned duties and responsibilities within the General Computer Systems Group in the Quality Assurance area, including SAP Quality Master Data, SAP Master Data Workflow, and Segmentation. Specific duties will include maintaining Quality Master Data in SAP for inspection plans, master inspection characteristics, sample drawing procedures and plans, maintaining Engineering Change Management in SAP, project team support for implementation of new SAP modules affecting Quality data, workflow completion of Quality data, and maintaining data integrity. The incumbent is an established and technically competent professional who independently develops and implements solutions to a variety of quality related objectives. He/she may lead 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 complexity, developing solutions for defined problems. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision. Extensive experience with SAP and the overall manufacturing process from pooling to packaged final container is preferred. Additional Responsibilities for Quality Associate II/III In addition to the duties described above the Quality Associate II/III may also perform the following duties based upon the business unit to which he/she is assigned: Quality Assurance General Computer Systems Management: 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, LIMS, 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. Sr. Quality Associate I/II The Senior Quality Associate I/II will be assigned duties and responsibilities within the General Computer Systems Group in the Quality Assurance area, including SAP Quality Master Data, SAP Master Data Workflow, Segmentation, and Data Integrity. Specific duties will include maintaining Quality Master Data in SAP for inspection plans, master inspection characteristics, sample drawing procedures and plans, maintaining Engineering Change Management in SAP, project team support for implementation of new SAP modules affecting Quality data, workflow completion of Quality data, and maintaining data integrity. The incumbent is an established and technically competent professional who independently develops and implements solutions to a variety of quality related objectives. He/she may lead 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 complexity, developing solutions for defined problems. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision. Extensive experience with SAP and the overall manufacturing process from pooling to packaged final container is preferred. Additional Responsibilities for Sr. Quality Associate I/II In addition to the duties described above the Sr. Quality Associate I/II may also perform the following duties based upon the business unit to which he/she is assigned: Quality Assurance General Computer Systems Management: 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, LIMS, 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.

Requirements

Quality Associate II - must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathmatics) discipline with a minium of 2 years relevant experince, or equivalent combination of education and experience.

Nice To Haves

Extensive experience with SAP and the overall manufacturing process from pooling to packaged final container is preferred.

Responsibilities

Coordinates SAP Quality related creations and changes in SAP and represents the department as an expert for SAP Master Data and all modules affecting Quality related data and processes.
Consults with management to develop and implement solutions for achieving quality related objectives.
Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
Uses expertise to make independent decisions within defined areas of responsibility.
Leads or participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion.
Collects and analyzes data.
Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports.
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

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