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Grifols Shared Services North America, Inc Sr. QA Supervisor in Clayton, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Job Level: M10

Hiring Manager: Michele Creech

Job Description

The Sr. Supervisor-Quality Assurance is primarily responsible for supervising or overseeing a group of employees performing tasks and assignments in the QA NFF business unit such as Quality support for Capital Projects and Validations, Change Control, Discrepancy Management, CAPA and other Pooling through Fractionation Batch Release activities that are required to support department cycle time goals. He/She participates in employee relations matters and is responsible for performance management in area of responsibility. The Sr. Supervisor-QA is a fully qualified, technically competent, professional who leads and participates on cross-functional project teams and requires minimal supervision.

Responsibilities include:

  • Ensure compliance with company policies and procedures and optimum use of staff and technical capabilities within defined areas.

  • Provide technical / non-technical expertise on quality related matters.

  • Provide guidance and consultation with manufacturing and internal regulatory departments on GXP matters.

  • Follow cGMP and department safety practices.

  • Provide effective leadership to employees in Quality.

  • Demonstrate high levels of values and integrity.

  • Consult with Quality Management, when necessary, regarding key decisions which need to be made within his/her defined area of responsibility.

  • Make sound quality decisions with minimal guidance

  • Prepare/review/approve various technical documents such as protocols, reports, investigations, risk assessments and annual product reviews.

  • Represent Quality at meetings and/or act on behalf of the Quality Manager when necessary.

  • Facilitate technical and non-technical training for other employees

  • Perform advanced 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

  • Provide Quality input and support for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions.

  • Interact with Senior members of management and/or regulatory officials

  • Make Quality related decisions that influence the direction of complex projects

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

Requirements

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.

Relevant experience must include:

  • Performing an advanced, independent role (such as author, reviewer, coordinator and/or approver) for multiple Quality System functions such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews, including review and/or approval of others’ work.

  • Demonstrate consistent application of their technical expertise as well as the use of various technical reference materials such as BPRs, SOPs, CFRs, cGMP, FDA & EU Regulatory Guidance Documents

  • Ability to be flexible and adapt to sudden changes in priorities and deadlines, multi-task, and work well under time constraints.

  • Ability to make sound quality decisions with minimal guidance.

  • Demonstrate high levels of value, integrity, and attention to detail.

  • Excellent communication skills (written and verbal)

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

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

Req ID: 81347

Type: Regular Full-Time

Job Category: Quality

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