QA Release Supervisor II/III

Grifols SA•Clayton, NC

50d•Onsite

About The Position

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. First Shift Supervisor II, QA: The Supervisor II, 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 occasionally represent quality in meetings. Specific duties will depend on the assignment and may include review of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc. (i.e. Documentation review, product investigations, product release, internal and external audit support, materials clearance, etc.). 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 on 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 responsible for training other employees. Supervisor III, QA: 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.

Requirements

Excellent communication skills (written and verbal) with familiarity of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
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
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.

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 company and department safety practices.
Provides effective leadership to employees in Quality.
Demonstrates high levels of value 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
Responsibilities may include roles (such as author, reviewer, 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.
Responsibilities include all above listed for Supervisor II.
Other duties as assigned