Quality Specialist 2

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.

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:

• Conducts compliance audits of more complex documentation and data and approve use of Design History Records, Device Master Records, Nonconformances, Document Changes, Validations and Change Controls.
• Demonstrates working knowledge of Quality Control, Manufacturing and Inventory processes.
• Serves as QA interface with limited responsibilities to other departments.
• Reviews Customer Notifications and prepare, approve & submit data packages for external customers.
• 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.
• Assists in developing quality systems & make recommendations for improvements to existing Quality systems.
• Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.
• Assists in chairing meetings as appropriate such as Complaint Review Board (CRB), Material Review Board (MRB) and Product Quality Committee (PQC), Change Control Board (CCB), and 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.
• Represents QA as an extended core team member on Core team and crossfunctional special project teams with minimal supervision.
• May conduct new employee quality system or procedural training and develop department training programs.
• Conducts technical troubleshooting activities & investigation analysis with minimal supervision.
• Performs technical support of QA Systems.
• Develops, maintains & reports department metrics, as needed.
• Reviews and assesses the appropriateness of document changes in accordance with internal procedure.
• Reviews and assesses change control, validation, and qualification documents, as applicable.

Knowledge, Skills, and Abilities:

• Working understanding of QSR & ISO requirements
• Working knowlege of QC, Manufacturing & Inventory processes
• 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.

Education:

• Requires BA or BS in a biological or chemical science.
• Quality certification (from American Society for Quality or equivalent), is a plus.

Experience:

At least 5 years related quality experience.

Equivalency:

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.

Occupational Demands:

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.

EEO Minorities/Females/Disability/Veterans
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