Grifols Shared Services North America, Inc Sr Quality Associate I/II in Clayton, North Carolina

Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

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, Data Integrity and Computer Systems Validation. 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.

Primary Responsibilities for Sr. Quality Associate I-

● 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.

Primary Responsibilities for Sr. Quality Associate II-

● 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.

● Use expertise to advise and influence the technical decisions of business units affecting SAP quality related data.

● 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 supervise or mentor employees.

● 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.

Additional Responsibilities for Sr. Quality Associate I-

In addition to the duties described above the Sr. Quality Associate I 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 roles (such as author, reviewer, 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 at business unit meetings and project meetings.

Additional Responsibilities for Sr. Quality Associate II-

In addition to the duties described above the Sr. Quality Associate I 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.

Shift: Day

Salary Grade: M08/M10

Requirements:

Sr. Quality Associate I- PHD in a Life Sciences degree with minimum of 2 years relevant experience. MS in a Life Sciences degree with minimum of 4 years relevant experience. BS in a Life Sciences degree with minimum of 6 years relevant experience, or equivalent combination of education and experience.

Sr. Quality Associate II- PHD in Life Sciences with minimum of 4 years relevant experience; MS in Life Sciences with minimum of 6 years relevant experience; or a BS in Life Sciences with minimum of 8 years relevant 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.

EEO Minorities/Females/Disability/Veterans

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 72841

Type: Regular Full-Time

Job Category: Quality