Grifols Shared Services North America, Inc NFB-Sr. Quality Associate II/Principal Quality Associate 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 - Sr. Quality Associate II (M09) / Principal Quality Associate, Quality Assurance (M10)
The Sr. Quality Associate II/Principal Quality Associate will primarily serve as a technical specialist for Quality System support for the NFB project as part of the QA NFF business unit. As project demands allow, the Sr. Quality Associate II/Principal Quality Associate will also perform manufacturing record review for Pooling through Fractionation Batch Release and other Quality Systems functions in order to transition from project operations to commercial operations.
- This position may require additional hours during evenings and weekends as needed to support project timelines.
Use expertise to advise and influence the technical decisions of business units.
Responsible for development, maintenance and vitality of essential Grifols technologies.
Interacts regularly with members of management and as needed with regulatory officials.
Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion.
May mentor employees.
Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports.
Demonstrates high levels of values and integrity.
Follows cGMP and department safety practices.
Demonstrated ability to make sound quality decisions with minimal guidance
Can easily multi-task, prioritize and adapt to changing business needs
Preparation/review/approval of regulatory document
Preparation of sections of the Annual Product Review as well as the overall APR
Demonstrated ability to influence decisions makers in other departments
Review and approval of validations
*Additional duties 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 at business unit meetings, and project meetings and will make quality decisions for the team that may influence the direction of complex projects.
Knowledge, Skills, and Abilities: Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administrations) and applicable foreign regulatory agency requirements/guidelines.
The successful candidate must demonstrate consistent application of their technical expertise and be able to perform an advanced, independent role (such as author, reviewer, and approver) for Investigations, CAPA, Change Control, Documentation, Validation, System Impact & Risk Assessments, Process Improvement and Capital Projects.
Experience supporting Capital Projects including equipment, utilities, & systems commissioning & validation, system & component impact assessments, risk assessments, process validation, and cleaning validation is also required.
*Preference will be given to candidates with knowledge of fractionation and associated manufacturing processes.
Required Education - Sr. Quality Associate II, QA (M9): BS/BA degree preferably in STEM( Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.
Required Education - Principal Quality Associate, QA (M10): 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.
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.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 74169
Type: Regular Full-Time
Job Category: Quality