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Senior QA Specialist

Company: Grifols
Location: San Diego
Posted on: May 19, 2019

Job Description:

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 over 20.000?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. The QA Sr. Specialist manages their own activities related to their area of expertise. They may also oversee and evaluate the work of others to ensure that it is compliant with the regulations of all countries where product is or will be distributed.Key point of contact to ensure compliance with and demonstrate knowledge of site level policies and regulations related to area of expertise. Provides significant guidance to others regarding their area of expertise.?Primary responsibilities for role:

Represent Quality Assurance on new product development teams, risk management teams and product surveillance teams Independently perform moderately complex tasks in their area of expertise. Ensures that all product associated documents, including product requirements, product development plans, protocols, reports, risk management documents, traceability matrices and product labeling are in accordance with HA regulations and company policies/standards. Cross-functional coordination with others as it relates to the regulations governing design control ?and risk during the lifecycle of each product. Interacts with regulatory and partner auditors/inspectors. Represents QA interests for the lifecycle of the product developed, manufactured, distributed to customers related to area of expertise.?Education: Bachelor?s Degree, in life or physical sciences.?MS in Quality Assurance, Regulatory Affairs, biotechnology or life science is desirable.?Experience:
Minimum of 8 years work experience, with a minimum of 6 years in a regulated (GMP/ISO/QSR) industry. QA experience desirable. Understanding of the requirements of 21 CFR parts 11, 210/211 and 820, ISO 13485, ISO 14971, IEC 62304, the In Vitro Diagnostics regulations of the European Union, Canada and other countries Experience with medical devices and/or in-vitro diagnostic medical devices, including reagent or hardware and software development are desirable Ability to quickly and logically evaluate and identify root cause of deviations or failures identify appropriate actions to correct problems and guide others to do the same. Ability to clearly and concisely document results of moderately complex projects, evaluations or investigations. Experience with management of third party manufacturers, suppliers and distributors is desirable?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 8 years of experience, an equivalency could include a Master?s degree and 4 years of experience?EEO Minorities/Females/Disability/Veterans
CLK789 Location:?NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg??Learn more about Grifols?

Keywords: Grifols, San Diego , Senior QA Specialist, Other , San Diego, California

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