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Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Execute the global RDQ audit program within the specified GxP discipline
- Conduct assigned audits and draft reports
- Work collaboratively with the GxP compliance area QA staff
- Assist in the development of a global audit program and schedule
- Perform external audits of clinical investigator sites, E-Systems, databases
- Perform self-inspections/audits of internal processes/procedures relevant to assigned GxP
- Develop, review, and issue Audit Reports outlining findings and recommendations
- Identify non-compliance trends and systematic risks for assigned GxP
- Support continuous improvement initiatives focusing on processes, procedures, and SOPs
Requirements
What you’ll need- BS degree in relevant biological science, science, or related discipline
- 3+ years of Quality Assurance experience within a GVP, GCP environment, preferred (other GxP environments will be considered)
- Strong analytical and demonstrated problem solving skills
- Excellent interpersonal/communication/influencing/negotiation skills
- Excellent organizational skills with respect to planning/tracking and timelines
- Demonstrated knowledge of QMS implementation and regulatory frameworks
- A strong understanding of the requirements for Quality Assurance in relevant GxP discipline
- Experience in audit/inspection management and processes
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxPQuality Assuranceaudit managementself-inspectionsQMS implementationregulatory frameworksanalytical skillsproblem solvingreport draftingcompliance trends
Soft Skills
interpersonal skillscommunication skillsinfluencing skillsnegotiation skillsorganizational skillsplanning skillstracking skillstimelines management
