Grifols Shared Services North America, Inc Quality Specialist 2 in San Diego, California
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.
Headquartered in Barcelona, Spain, Grifols has nearly 18,500 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensures that deadlines are met on time and within budget. Quality interface with other departments and business or marketing partners. Work independently with minimal supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
Primary responsibilities for role:
Serves as QA interface and support for quality systems questions, Internal/external audits, and supplier quality management.
Supports internal and/or external audits in compliance with ISO 13485 and 21CFR820 requirements.
Participates in 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business partners.
Conducts quality system compliance audits of more complex documentation and data and approves use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls
Supports efforts in supplier management including: maintaining Approved Supplier List, and performing Desktop Audits, Supplier/Audit Risk assessments, Supplier Evaluation/Selection, Supplier Performance Monitoring, etc
Represents QA as it relates to quality systems, audits and supplier quality management in cross functional project teams with minimal supervision.
Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
Reviews and assesses the appropriateness of document changes in accordance with internal procedure.
Reviews and assesses change control, validation, and qualification documents, for impact to quality systems.
Provides quality system support in meetings such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), as well as other meetings.
Prepares appropriate Agendas and meeting minutes with minimal supervision.
Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.
Provides quality system support for technical troubleshooting activities & investigation analysis with minimal supervision.
Knowledge, Skills, and Abilities:
Travel is required up to 25% of the time.
Working understanding of QSR & ISO requirements
Working knowledge of Quality System Audits and Supplier Quality Management
Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs.
Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.
Must demonstrate initiative, balanced assertiveness, flexibility and team orientation.
Requires BA or BS in a biological or chemical science.
Quality certification (from American Society for Quality or equivalent), is a plus.
At least 5 years related quality experience.
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. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously. Sedentary work involves sitting the majority of time. Jobs are sedentary if walking and standing are required only occasionally.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home