R&D Quality Assurance Audit Specialist Job At Grifols in North Carolina – Apply Now!
Are you passionate about ensuring quality and compliance in the healthcare sector? Grifols, a global leader in plasma-derived medicines and transfusion medicine, is looking for an R&D Quality Assurance Audit Specialist to join its team in North Carolina. If you’re ready to contribute to the future of healthcare and improve the lives of millions, this is your chance to be a part of an innovative company with a long-standing legacy in healthcare excellence.
About Grifols
Grifols is an international healthcare company that has been working to improve health and well-being since its founding in 1909. With a strong presence in over 110 countries, Grifols specializes in plasma-derived medicines and transfusion medicine. The company develops, manufactures, and markets innovative medicines, solutions, and services that help enhance patient care around the world. Grifols is committed to advancing healthcare and improving the quality of life for millions by ensuring the highest standards in quality assurance, compliance, and innovation. Their mission has always been driven by a dedication to improving human health, with an emphasis on plasma therapies, biotechnology, and global healthcare solutions.
Job Details:
Job Posting: R&D Quality Assurance Audit Specialist
Location: NC-RTP, US
Contract Type: Regular Full-Time
Area: Quality
Req Id: 524533
Main Responsibilities:
Supervision of Documentation Generated by Pre-Clinical SIO Groups
- Review of primary data related to studies, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GMP, GLP).
- Review and approval of study protocols and reports, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GLP).
- Review and approval of procedures, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GLP).
Audits
- Participation in the planning of the R&D QA Annual Audit Plan to define internal audits for various SIO Pre-Clinical groups, based on procedures, risk analysis, and new studies.
- Conducting scheduled internal audits for SIO Pre-Clinical groups, which may include facilities or studies.
- Conducting audits requested by other groups external to SIO Pre-Clinical, within the expertise area of R&D QA.
Vendor Qualification
- Conducting the qualification and re-qualification process for vendors used by SIO Pre-Clinical groups.
- Conducting qualification and re-qualification audits for vendors, as deemed necessary.
- Conducting qualification and re-qualification audits requested by other Grifols Quality groups, within the expertise area of R&D QA.
R&D Quality System
- Review and approval of deviations from groups generated under the supervision of R&D QA.
- Management, review, and approval of CAPAs from groups generated under the supervision of R&D QA.
- Monitoring KPIs related to Quality Management of groups under the supervision of R&D QA. Compilation and drafting of the R&D Quality Annual Report.
- Participation in adapting the R&D Quality System to new situations that may arise. Drafting and reviewing procedures.
- Acting as a Quality expert within multidisciplinary teams for new Grifols projects.
- Managing and collaborating with IT in the technical maintenance of the R&D Quality System.
- Communication with different groups located worldwide.
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: Minimum 2 years, preferably 5, in a similar role or relevant experience in Quality
Keywords: Grifols, R&D Quality Assurance Audit Specialist, Quality, Healthcare, Compliance, Pharma Regulations
