Sr. Supervisor​/Supervisor III, QA; Filling and Utilities

Sr. Supervisor / Supervisor III, QA (Filling and Utilities)

Location:

NC-Clayton, US

Contract Type:
Regular Full-Time

Area: TECHNICAL

Shift: Day Shift

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.

The Sr. Supervisor, Quality Assurance is responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility. May facilitate technical and non‑technical training. Specific duties will depend on the assignment and may include reviewing manufacturing or testing records, preparing or reviewing failure investigations, product/raw material sampling and/or testing, sampling/testing/data analysis of environmental monitoring samples and data, auditing, data analysis for stability, etc.

The incumbent is a professional with high technical competency who leads project or discipline teams. May make quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. The incumbent provides leadership and guidance to others and may be responsible for training other employees. Serves as a delegate for the Quality Manager.

• Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.
• Ensure compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
• Provide technical / non‑technical expertise on quality‑related matters.
• Provide guidance or consult with manufacturing and internal regulatory departments on quality matters.
• Follow cGMP and department safety practices.
• Provide effective leadership to employees in Quality.
• Demonstrate high levels of values and integrity.
• Consult with Quality Sr. Management regarding key decisions within area of responsibility.
• Independently make sound quality decisions.
• Influence decision makers in other departments.
• Prepare, review and approve regulatory documents.
• Prepare sections of the Annual Product Review and the overall APR.
• Interact regularly with members of management and regulatory officials.
• Other duties as assigned or as specified in the Additional Responsibilities section may apply.

The Supervisor III, Quality Assurance is responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility. May facilitate technical and non‑technical training. Responsibilities may also include 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 as well as provide quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and regulatory submissions.

Responsible for representing quality meetings. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision.

• Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.
• Ensure compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
• Provide technical / non‑technical expertise on quality‑related matters.
• Provide guidance or consult with manufacturing and internal regulatory departments on…