Sr QA Specialist Details

Sr QA Specialist

Grifols Diagnostic Solutions Inc - San Diego, CA

Employment Type : Full-Time

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.

Summary:

The Sr. QA Specialist participates on project core teams related to new product development (NPD). In this role, the employee will work closely with personnel from other departments.

This role will also be responsible for performing system validations when reagents, software, and/or hardware are modified in previously validated products.

Key point of contact to ensure compliance with and demonstrate knowledge of site level policies related to new product development and system validations.

Primary responsibilities for role:

• Independently performs moderately complex tasks (such as writing procedures/reports and performing validations) in support of NPD and system validation.
• Ensures governing documents for NPD and system validations are in accordance with HA regulations (such as ISO 13485 and 21 CFR 820) and company policies/standards.
• Cross-functional coordination with other departments as it relates to NPD and system validation.
• Interacts with regulatory and partner auditors/inspectors.
• Represents QA interests on special projects related to NPD and system validation.

Education:

Requires degree(s) in molecular biology, biology, chemistry, biomedical engineering, computer science or a related field. • Quality certification (from American Society for Quality or equivalent), is a plus.

Experience:

Previous experience with new product development and/or assay development a must.
Experience following and implementing design controls is a must.
New product development of software and/or hardware is a plus.
Experience with leading and/or performing investigations is a plus.

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. For this role, a Bachelor's degree + 6 years experience, a Master's degree + 4 years experience, or a PhD + 2 years experience are acceptable.

Occupational Demands:

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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