Sr. Supervisor / Supervisor III, QA (Filling and Utilities)
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. Sr. Supervisor, Quality Assurance / Supervisor III, Quality Assurance: Summary for Sr. Supervisor, QA: 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; review of manufacturing or testing records, preparation or review of 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 and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional. Serves as a delegate for the Quality Manager. Summary for Supervisor III QA: 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. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Requirements
- BS/BA preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of BA/BS is required.
- 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.
- Excellent communication skills (written and verbal) with familiarity with domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
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
- Preparation of sections of the Annual Product Review as well as the overall APR
- 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.
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
