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Grifols Shared Services North America, Inc Supervisor III, Quality/Sr. Supervisor, Quality in Clayton, North Carolina

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: 8:00 am to 5:00 pm

The Supervisor, Quality Assurance is responsible for supervising employees engaged in performing various Quality Assurance tasks in support of the packaging area. Specific duties may include the following: QO audit documentation completion/review/approval, review/verification of manufacturing or testing records, SAP QM entries, preparation or review of product investigations, review of validation documentation, product release, internal and external audit support, resolution of product technical complaints etc.). Executes assignments of medium complexity, developing solutions for defined problems. Trains others at the entry level. Participates in employee relations matters, performance management and other duties as assigned. The incumbent is an established and technically competent professional who develops and implements solutions to a variety of quality-related objectives. He/she may participate in 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 is a fully qualified professional who requires minimal supervision.

Primary Responsibilities

● Supervise all aspects of a group of employees engaged in Quality Assurance tasks supporting the packaging area.

● Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.

● Provides technical / non-technical expertise on quality related matters.

● Provides guidance or may consult with manufacturing and internal regulatory departments on GXP matters.

● Follows cGMP and department safety practices.

● Provides effective leadership to employees in Quality.

● Demonstrates high levels of values and integrity.

● May consult with Quality Management regarding key decisions which need to be made within his/her defined area of responsibility.

● Demonstrated ability to make sound quality decisions with minimal guidance

● Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests

● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

The Sr. Supervisor, Quality Assurance is responsible for supervising employees engaged in performing various Quality Assurance tasks in support of the packaging area. Specific duties may include the following: QO audit documentation completion/review/approval, review/verification of manufacturing or testing records, SAP QM entries, preparation or review of product investigations, review of validation documentation, product release, internal and external audit support, resolution of product technical complaints etc.). Executes assignments of medium complexity, developing solutions for defined problems. Trains others at the entry level. Participates in employee relations matters, performance management and other duties as assigned. The incumbent is an established and technically competent professional who develops and implements solutions to a variety of quality-related objectives. He/she may participate in 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 is a fully qualified professional who requires minimal supervision.

Serves as a delegate for the Quality Manager.

Primary Responsibilities

● Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.

● Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.

● Provides technical / non-technical expertise on quality related matters.

● Provides guidance or may consult with manufacturing and internal regulatory departments on Quality matters.

● Follows cGMP and department safety practices.

● Provides effective leadership to employees in Quality.

● Demonstrates high levels of values and integrity.

● May consult with Quality Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.

● Demonstrated ability to independently make sound quality decisions

● Demonstrated ability to independently influence decision makers in other departments.

● Preparation/review/approval of regulatory documents.

● Interacts regularly with members of management and as needed with regulatory officials.

● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

Requirements

Candidates for the Supervisor III-QA : BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 6 years relevant experience, or equivalent combination of education and experience.

Candidates for the Sr. Supervisor-QA: BS/BA in preferably in STEM( Science, Technology, Engineering, and Mathematics) dicsipline with a minimum of 8 years relevant experience. A minimum of a BA/BS is required.

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.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 527453

Type: Regular Full-Time

Job Category: Quality

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