R&D QA & Audit Specialist
RTP, NC, USA
Grifols
About the Position
Grifols is seeking a dedicated QA professional in RTP, NC to join our global R&D QA team within the Scientific Innovation (SIO). In this role, you will perform quality tasks under the oversight of R&D QA which includes supporting primarily R&D/CMC Development (e.g., Bianalytics, Pathogen Safety, and Process Development & Technology) ensuring compliance to Grifols’ quality system (e.g., internal procedure) and applicable regulations/guidelines (GLP, GMP and GCLP), when applicable.
Main Responsibilities
- Review documents such as procedures, protocols, and reports.
- Conduct audits (e.g., facility, data, and process) and vendor qualification/audits.
- Manage, review, and approve deviations and CAPAs generated.
- Monitor KPIs related to Quality Management.
- Participate in adapting the R&D Quality System to new situations that may arise.
- Manage and collaborate with IT in the technical maintenance of the R&D Quality System.
- Communicate with various SIO departments/groups and different groups located worldwide as the quality expert or other.
Knowledge, Skills, and Abilities
Strong integrity and commitment to quality and compliance, with the ability to understand pharma-related regulations and proficiency with computers. Ability to work flexible schedules to meet business needs, demonstrating good organizational skills, and attention to detail. A high capacity for teamwork is required to work daily with different groups, developing strong interpersonal communication, organizational, and problem-solving skills. Additionally, analytical, evaluative, and sometimes conflict resolution skills are necessary.
Education
Life Sciences Degree
Experience
A minimum of 2 years, preferably ≥5, in a similar role or relevant experience in Quality.
Submit resumes to [email protected]
21 May 2025