Supervisor II/III - QA (Final Container Release)

GRIFOLS, S.A.

4d•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. The Supervisor Quality Assurance II, and III, QA Fractionation business unit is primarily responsible for supervising or overseeing a group of employees performing tasks and assignments, including pre-pooling release of plasma pool shipments, assessment of plasma post donation & lookback alerts, preparation of pool sample shipments to the PEI and/or UK, and manufacturing record review for Pooling through Fractionation Batch Release to support department cycle time goals. He/She participates in employee relations matters and is responsible for performance management in area of responsibility. The Quality Assurance Supervisor II/III is a fully qualified professional who requires minimal supervision and is responsible for performing tasks and making decisions related to multiple Quality Systems, and developing and implementing solutions to a variety of Quality related issues or objectives. He/she may also participate on cross-functional teams of varying scope and provide leadership and guidance to others. Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.

Requirements

Candidates for the Supervisor II-QA must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 5 years relevant experience, or equivalent combination of education and experience.
Candidates for the Supervisor III-QA must have a 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.
Performing an advanced, independent role (such as author, reviewer, coordinator and/or approver) for multiple Quality System functions such as Change Control, Discrepancy Management, Batch Release, SAP, SAP Quality Module, Documentation, Annual Product Reviews, Risk Assessments and CAPA.
Review and/or approval of others’ work such as batch records, investigation reports, ETPs, validation protocols, etc.
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)

Nice To Haves

Preference will be given to candidates with knowledge of plasma receiving, pooling, fractionation, and associated manufacturing processes.

Responsibilities

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 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.
Prepares and reviews SOP revisions, technical reports in DCM, failure investigations, and sampling/testing/data records
Make sound quality decisions with minimal guidance
Represent Quality at meetings
Facilitate technical and non-technical training for other employees.
Perform advanced roles (such as author, reviewer, approver, or coordinator) in all Quality Systems such as Change Control, Discrepancy Management, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews.
Provide Quality input 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 and lead project teams.