What are the responsibilities and job description for the GCP QA Auditor position at Actalent?
Role: Clinical Quality Assurance Auditor - GCP QUALITY
Company: Growing pharmaceutical company!
Job Duties:
- Provide day to day GCP consultation for clinical and regulatory affairs staff, reviews and approves study-related documents as required by SOPs and audit plans (e.g. protocols, Clinical Study Reports, Informed Consent, Case Report Form, etc).
- Author SOP’s and Policies to support the overall QMS.
- Responsible for making quality related decisions for all on-going studies.
- Determines the frequency of audits of study documents and Trial Master Files.
- Prepares and maintains audit schedules for investigational sites as needed;
- Performs audits of representative samples of investigator sites participating in clinical studies at various stages of process conduct (phases I to IV);
- Reviews Investigator Study File to assess compliance with Regulations;
- Prepares, executes assessments/audits and write reports; interacts with external auditors and oversee their auditing activities; coordinates site and vendor inspections.
- Performs audits/assessment of vendors to ensure they are acceptable for the responsibilities being contracted to them;
- Responsible for maintaining quality and ensuring that studies, documents, and submissions to regulatory agencies meet required industry and government standards. Ensure adherence to company policies, SOPs and quality systems supporting the clinical operations department.
- Perform and manage quality audits of vendors, clinical sites, and partners to ensure compliance with regulation, PV agreements and SOPs. Host GxP regulatory and partner inspections.
Benefits Included Below: 100% REMOTE travel to sites for audits
- Medical, dental & vision
- 401(k)/Roth
- Insurance (Basic/Supplemental Life & AD&D)
- Short and long-term disability
- Health & Dependent Care Spending Accounts (HSA & DCFSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $70 - $95
