Quality Specialist 3

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 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 and exercise judgment within the defined procedures and practices to determine appropriate actions. 

Primary responsibilities for role:

• Conducts compliance audits of difficult & complex documentation and data
•  Leads Nonconformances, CAPAs and Change Control processes.

• Demonstrates working knowledge of Quality Control, Manufacturing and Supply Chain processes.

• Leads internal, external & 3rd party audits.

• Serves as QA interface with limited responsibilities to other departments.

•  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.

• Interfaces with other departments and business partners for complaints, investigations, etc.

• Chairing meetings as appropriate such as  Product Response Team meetings, investigations meetings, CAPA implementation meetings, Change Control coordination meetings, etc.

• Prepares appropriate Agendas and meeting minutes.

• Monitors the progress of items on the meeting Agendas and reports progress, as appropriate.

•  Chairs meetings & represents QA as an extended core team member on Core team and crossfunctional special project teams.

• May conduct new employee quality system or procedural training and develop department training programs.

• Conducts complex technical troubleshooting activities & investigation analysis.

•  Performs technical support of QA Systems.

•  Develops, analyze, trend, 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.

• Provide technical review for validations.

• Assists in developing quality systems & make recommendations to existing Quality systems.

•  Administers QA Programs such as Audit, ECO/DCR CAPA & QSR.

•  Develops & maintains department training programs.

• Review and assess the appropriateness of document changes in accordance with internal procedures of a difficult and complex nature.

• Assists in decision making at meetings for recalls, MDRs, field corrections &/or market recalls.

• Acts as a mentor to QA personnel.

• Working understanding  of QSR & ISO requirements
• Advanced knowlege of QC, Manufacturing & Supply Chain.
• Working knowledge of Microsoft Word, Excel, Power Point and related functions including the formulation of graphs.

• Knowledge in biochemistry, molecular and cellular biology.

• Knowledge of in vitro diagnostics products, medical devices and blood banking.
• Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential.  

• Communication skills are essential.
• Must demonstrate initiative, independence, 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

• 5-8 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

Additional Details:
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.