An award winning, client-focused CRO is looking for an experienced GCP Auditor to join their growing Quality Assurance team! This role is remote role and has very limited US based travel, offers incredible professional development opportunity with a supportive, high achieving team.
- Assist with maintaining the Quality Management System (QMS) consistent with current GCP, GDP, and other applicable regulatory and ethical requirements.
- Prepare, conduct, and execute follow up of internal/external audits: documentation audits (TMF, CSR), vendor audits of current and potential vendors, GCP inspections
- Generate and review SOPs, guidance forms and templates, follow up of quality events, CAPAs and deviations.
- Assist with tracking of GCP quality system metrics such as quality events, CAPAs, deviations and audit findings.
- Participate in computer system validation and change control activities.
- Interface with clients, internal and external stakeholders, and vendors, as needed.
- Adhere to all aspects of internal Quality Management System.
- Bachelor's degree (B.A./B.S.) or equivalent in a scientific, computer, or related discipline.
- 1+ year of hands on GCP Auditing experience (required)
- Minimum 1-3 years experience in quality within a Clinical Research Organizationsetting
- Understanding of ICH Guidelines for Good Clinical Practices (GCP), Title 21 CFR, and industry guidelines, regulations, and standards/
- Must have a valid driver's license with no limitations on driving availability.
- Ability to travel up to 10-15%
- Full remote with limited travel
- Competitive salary and benefits package, 401k Match
- Week off between Christmas and New Years
- Strong PTO package with additional VTO (Volunteer Time Off) to give back to local community.
- Collaborative internal company culture with emphasis on professional development and training.