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

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.

Shift: 1st - M-F 8:00am - 4:30pm

The Sr. Quality Associate I/II/Principal Quality Associate will primarily serve as a Quality Systems technical specialist as part of the QA Fractionation business unit. He/She will develop and implement solutions to a variety of quality related objectives to support department goals including executing assignments of medium complexity and developing solutions for defined problems. The Sr. Quality Associate I/II/Principal Quality Associate will also perform manufacturing record review for Pooling through Fractionation Batch Release and other related Quality functions to support department cycle time goals and objectives. He/She will provide leadership and guidance to others, including training other employees and representing the Quality unit when necessary.

Responsibilities:

  • 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 and may influence technical decisions of complex projects and/or business units.

  • Participates on, and may lead, 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, technical reports in DCM, Change Control Requests, Incident Tracking System entries and investigation reports.

  • Demonstrated ability to make sound quality decisions with moderate to minimal guidance

  • Prepares, reviews and/or approves Incident Tracking System entries and investigation reports.

  • Demonstrates high levels of values and integrity.

  • Follows cGMP and department safety practices.

  • May mentor employees based on experience

  • Additional duties may include 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, Risk Assessments, 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. May also interact regularly with members of management and as needed with regulatory officials, and be responsible for development, maintenance and vitality of essential Grifols technologies.

Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.

Knowledge, Skills, and Abilities: Demonstrated consistent application of technical knowledge and expertise. Excellent communication skills (written and verbal) and attention to detail. Knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and lead/drive any necessary changes.

Knowledge of plasma release, pool and/or fractionation and associated manufacturing processes is a plus, although not required.

Required Experience:

The successful candidate must demonstrate consistent application of their technical expertise and have experience performing an advanced, independent role (such as author, reviewer, coordinator and/or approver) for multiple Quality Systems such as Discrepancy Investigations, CAPA, Batch Release, SAP Quality Module, Change Control, Documentation, Validation, System Impact & Risk Assessments, and Process Improvement.

Experience reviewing and/or approving others’ work such as batch records, investigation reports, ETPs, validation protocols, etc. is required.

Experience supporting Continuous Improvement and Capital Projects including commissioning & validation, system & component impact assessments, risk assessments, process validation, and cleaning validation is also required.

Required Education

Sr. Quality Associate I, QA: 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.

Sr. Quality Associate II, QA: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.

Principal Quality Associate : BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS degree is required.

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/Women/Disabled/Veterans

Req ID: 434130

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