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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.
Hours: Monday to Friday - 8:00 am - 4:00 pm
The Quality Supervisor II/III in the QA Fractionation business unit will be responsible for supervising or overseeing a group of employees performing Contract Intermediate Quality Release functions for import and export fractionation shipments. He/she will participate in employee relations matters and is responsible for performance management in area of responsibility, including activities to support department cycle time goals. The Quality Supervisor II/III is a fully qualitied professional who requires minimal supervision and serves as a technical specialist in their area of responsibility. 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 Quality Supervisor II/III will also perform tasks for Pooling through Fractionation Batch Release and other related Quality functions. He/she may also participate on cross-functional teams of varying scope and provide leadership and guidance to others.
Responsibilities:
Ensures optimum use of staff within area of responsibility and monitors performance 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. Collects and analyzes data Prepares, reviews, and in some cases approves, SOP revisions, technical reports in DCM, Change Control Requests, discrepancy investigation reports and sampling/testing/data records. Demonstrated ability to make sound quality decisions with moderate to minimal guidance Facilitate technical and non-technical training for other employees, including direct reports, and provide effective leadership to other employees. Demonstrates high levels of values and integrity. Follows cGMP and department safety practices. 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, 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.
Required Experience:
Must be qualified to perform an advanced, independent role (such as author, reviewer, coordinator and/or approver) for Quality Systems within defined area of responsibility such as Batch Release, SAP Quality Module, Discrepancy Investigations, CAPA, Change Control, Documentation, Annual Product Reviews, Compliance Audits, and Risk Assessments.Experience performing Quality Release functions for plasma, pooling and fractionation that may include plasma pool shipment release, batch record review, pooling/fractionation batch disposition, contract fractionation import/export shipment release along with all applicable SAP Quality transactions is required.
Previous supervisory experience including employee performance evaluations is preferred, although not required
Required Education
Quality Supervisor II, QA (M08): 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.
Quality Supervisor III, QA (M09): 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.
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.
Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton
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