Grifols Shared Services North America, Inc Sr. Quality Associate I / Sr. Quality Associate II / Principal Quality 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.
Sr. Quality Associate I / Sr. Quality Associate II / Principal Quality Associate, QA
The Sr. Quality Associate I,/Sr.Quality Associate II/Principal Quality Associate will primarily serve as a technical specialist for Quality System support for filling. The incumbent may also serve as technical specialist for the QA Fill/Pack/Utility group, and other quality functions within the Quality unit in order to support commercial operations.
Consults with management to develop and implement solutions for achieving quality related objectives.
Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
Uses expertise to make independent decisions within defined areas of responsibility.
Participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion.
Collects and analyzes data
Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
Demonstrated ability to make sound quality decisions with moderate guidance
Prepares reviews and/or approves Incident Tracking System entries and investigation reports.
Demonstrates high levels of values and integrity.
Follows cGMP and department safety practices.
Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
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). Has basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.
Required Experience: 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 filling, QA and associated processes.
Sr. Quality Associate I (M08)- Required Education/Experience: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.
Sr. Quality Associate II (M09)- Required Education/Experience: 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.
Principle Quality Associate (M10) - Required Education/Experience: BS/BA degree preferably in 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: 78702
Type: Regular Full-Time
Job Category: Quality