Principal Quality Associate, QA Filling

Join to apply for the Principal Quality Associate, QA Filling role at Grifols Shared Services North America, Inc.

Hours:

Monday to Friday – 8:00 am to 5:00 pm

Grifols is a global healthcare company that has been working to improve health and well‑being worldwide since 1909. We lead in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries.

• Use expertise to advise and influence technical decisions of business units.
• Develop, maintain and enhance essential Grifols technologies.
• Interact regularly with management and regulatory officials.
• Lead multi‑disciplinary project teams with highly technical objectives and communicate project proposals to senior management.
• Prepare, review and, when required, approve SOP revisions, change control requests, incident tracking system entries and investigation reports.
• Prepare, review and approve regulatory documents and sections of the Annual Product Review.
• Review and approve validations and other quality system activities (Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, Documentation, APR).
• Other duties as assigned.

• BS/BA in a STEM discipline with a minimum of 8 years relevant experience.
• Strong knowledge of FDA and applicable foreign regulatory guidelines.
• Excellent written and verbal communication skills.
• Demonstrated ability to make independent sound quality decisions and influence other departments.
• Ability to work independently and manage multiple priorities.

Clayton, North Carolina, United States (North America – USA – NC‑Clayton)

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, protected veteran status or spouse/family member of a protected veteran or disability. We will consider for employment all qualified applicants consistent with the requirements of all applicable laws.