Grifols Shared Services North America, Inc Quality Associate I/II/III in Clayton, North Carolina
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
The Quality Associate I/II/III in the QA Fractionation business unit performs manufacturing batch record review for Pooling through Fractionation Batch Release to support department cycle time goals. He/She also performs pre-pooling release of plasma pool shipments to support production schedules, assessment of plasma post donation & lookback alerts, preparation of pool sample shipments to the PEI, and review of miscellaneous manufacturing records. He/she may also be responsible for coordinating work assignments, training of other employees, writing and/or revising procedures, and providing routine technical support for various tasks, assignments, and projects.
Collects, reviews and may analyze data and generate department reports
Makes decisions within a well-defined area that may influence the department goals
Addresses and resolves problems according to written procedures (eg. SOP) or practice
Communicates effectively and promptly, supporting department objectives and management decisions
Demonstrates high levels of values and integrity
Follows cGMP and department safety practices
May train other employees
Additional responsibilities may also include:
Execute assignments of medium complexity
Develop solutions to defined problems
Collect, review and analyze data
Perform roles (such as author, reviewer, approver, administrator or coordinator) in Quality Systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews
May also provide Quality input for validation, capital projects, ETPs, Regulatory submissions, or other studies
Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.
2nd shift Sunday- Thursday 3:00 PM-11:30 PM
Knowledge, Skills, and Abilities:
Excellent communication skills (written and verbal) and attention to detail. Has basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Preference will be given to candidates with knowledge of plasma release, pooling and/or fractionation processes.
Candidates for the Quality Associate I must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) or equivalent combination of education and experience.
Candidates for the Quality Associate II must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience.
Candidates for the Quality Associate III must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or equivalent combination of education and experience.
Relevant experience should include:
Demonstrate consistent application of their technical knowledge and expertise and attention to detail
Ability to be flexible and adapt to sudden changes in priorities and deadlines, multi-task, and work well under time constraints.
Review and/or approval of others' work such as batch records, test data etc.
Performing roles (such as author, reviewer, coordinator and/or approver) for one or more Quality System function such as Change Control, Discrepancy Management, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews
Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32
- in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
Req ID: 482839