Grifols Shared Services North America, Inc Supervisor III-QA / Sr. Supervisor-QA 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.
The Supervisor III/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, including pre-pooling release of plasma pool shipments, assessment of plasma post donation & lookback alerts, preparation of pool sample shipments to the PEI, 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 Supervisor III/Sr. Supervisor-QA is a fully qualified professional who requires minimal supervision.
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.
Make sound quality decisions with minimal guidance
Represent Quality at meetings
Additional responsibilities may also include:
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 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 or lead project teams
Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.
Candidates for the Supervisor III-QA : 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.
Candidates for the Sr. Supervisor-QA: 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 one or more Quality System function 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)
Hiring Manager: Michele Creech
Position Level: M9/M10
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 80727
Type: Regular Full-Time
Job Category: Quality