Grifols Shared Services North America, Inc NFB-Principal Associate, 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.
NFB - Principal Quality Associate, Quality Assurance (M10)
The Principal Quality Associate will primarily support Quality Computer System Validation for the NFB project. The incumbent is a professional with high technical competency who leads project or discipline teams. Can make quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. Can identify continuous improvement opportunities and drive the change and assess impact to other areas of the business. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision. Serves as delegate to the manager.
Quality review and approval of validation documents related to the automation validation and computer systems including review for compliance with Grifols policies and procedures, regulatory requirements and technical expertise.
Support any compliant requirements of FDA audits, internal and external audits and regulatory affairs commitments.
Support data integrity initiatives.
Support Change Control requests for manufacturing computer systems.
Support any new product/market growth and existing projects as required for computer validation through quality consulting and timely review/approval of computer validation documents.
Demonstrated ability to independently make sound quality decisions
Demonstrated ability to influence decisions makers in other departments
Review and approval of validations
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
In addition to the duties described above the Principle Quality Associate, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned:
Responsibilities may 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 manager at business unit meetings, and project meetings.
Knowledge Skills and Abilities
Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be able to work independently.
Principal Quality Associate- BA/BS degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS is required. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.
SALARY GRADE M10
Hiring Manager: Jennifer Long
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.
This position is Employee Referral Bonus Eligible
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 77789
Type: Regular Full-Time
Job Category: Quality