Principal Quality Associate, QA Filling

Principal Quality Associate

Hours:

Monday to Friday - 8:00 am to 5:00 pm

• Use expertise to advise and influence technical decisions of business units.
• Responsible for development, maintenance and vitality of essential Grifols technologies.
• Interact regularly with members of management and as needed with regulatory officials.
• Lead multi-disciplined project teams with highly technical objectives; communicate project proposals to senior management and follow project through to successful completion.
• Prepare, review, and in some cases approve SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports.
• Demonstrate high levels of values and integrity.
• Multi-task, prioritize and adapt to changing business needs.
• Preparation, review and approval of regulatory documents.
• Preparation of sections of the Annual Product Review as well as the overall APR.
• Demonstrated ability to independently make sound quality decisions.
• Demonstrated ability to influence decision makers in other departments.
• Review and approval of validations.
• Other duties as assigned or as specified in the Additional Responsibilities section may apply.

• Author, reviewer, approver, administrator or coordinator roles in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews.
• Provide quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and regulatory submissions.
• Represent Quality manager at business unit meetings and project meetings.

• BS/BA degree preferably in a STEM discipline with minimum of 8 years relevant experience.
• BS/BA is required
  .

• Excellent communication skills (written and verbal).
• Demonstrated use of domestic (FDA) and applicable foreign regulatory agency requirements/guidelines.
• Ability to work independently.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.