Clinical QA Audits Specialist

Grifols; North Carolina; On-site; USD 110,000 - 125,000; Full time

Job summary

Join a forward-thinking global healthcare company dedicated to improving lives through innovative solutions. As a Clinical QA Audits Specialist, you will be integral in ensuring compliance and quality assurance across clinical trials. Your expertise will contribute to audits of CROs, vendors, and clinical sites, ensuring adherence to regulations. This role offers the opportunity to work in a dynamic environment, making a real impact on healthcare while collaborating with a passionate international team. If you are driven by quality and compliance, this is the perfect opportunity for you.

Qualifications

• 3+ years experience in GCP and GCLP quality assurance.
• Ability to conduct audits and prepare reports.

Responsibilities

• Plan and conduct audits of CROs and clinical trial sites.
• Prepare audit reports and track findings.

Skills

GCP Quality Assurance

GCLP Compliance

Audit Planning

Regulatory Inspection Preparation

Education

Ph.D. in Pharmaceuticals

Master's in Life Sciences

Bachelor's in Life Sciences

Job description

Join to apply for the Clinical QA Audits Specialist role at Grifols

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Join to apply for the Clinical QA Audits Specialist role at Grifols

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Primary Responsibilities

• Plan and conduct audits of CROs, vendors, clinical trial sites, and documentation associated with clinical trials. Assess compliance with applicable regulations and standards.
• Conduct internal audits of Clinical GCP processes for adherence to SOPs, company policy, and regulations/standards.
• Contribute to the review of the internal procedures related to the planning, conduct and oversight of clinical audits.
• Prepare audit reports and discuss findings with auditees and internal customers. Track and follow up on the resolution of audit findings.
• Provide guidance to Clinical staff in resolving audit findings in a compliant manner.
• Assist internal groups in preparing for inspections by regulatory agencies and participate in on site regulatory inspections as appropriate.
  
  
  

Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required.

• You have a Ph.D. Master, Bachelors in pharmaceuticals or life sciences related field.
• You have at least 3 years of practical experience in GCP and GCLP quality assurance or compliance.
• You are available to travel.
  
  
  

Third Party Agency And Recruiter Notice

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-RTP : USNC0001 - RTP NC-Headquarters

Learn more about Grifols

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Accounting/Auditing and Finance

• Industries

  Pharmaceutical Manufacturing and Medical Equipment Manufacturing

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