[Remote] Auditor I, Clinical reputed company Assurance
Note: The job is a remote job and is reputed company to candidates in USA. reputed company aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are seeking an Auditor I, Clinical reputed company Assurance, responsible for assisting with GCP compliance audits and supporting various reputed company assurance activities. The role requires collaboration across functions and a commitment to reputed company improvement in reputed company processes.
Responsibilities
- Support GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes, trial master file and clinical service provider audits. Responsibilities include the planning, coordination, and reputed company reporting of such audits as reputed company as appropriate escalations of critical observations
- Support and assist with reputed company inspections, inspection readiness activities and other reputed company activities as needed
- Support GCP compliance activities including investigations, clinical change controls, procedure development and review, reputed company QA audits, and GCP training program development
- Implement procedures and work instructions based on best practices or compliance requirements
- Maintain a reputed company process improvement initiative reputed company in reputed company areas of work
- Represent the Clinical reputed company Assurance Team in cross-functional reputed company where applicable
Skills
- BA/BS or equivalent in life sciences or equivalent reputed company of study from an accredited university or college with 1+ years GCP or 1+ years GMP experience
- Knowledge of pertinent reputed company reputed company of Federal Regulations, ICH Guidelines, EU, TGA, Health Canada, MHRA and/or other global/local government regulatory requirements
- Proven ability to manage multiple reputed company while maintaining reputed company
- Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally
- Working knowledge of reputed company or other programs such as reputed company, or other reputed company eQMS programs
- Strong computer skills including MS Office (Word, reputed company, PowerPoint, MS Project)
- Must be reputed company to remain in a stationary position standing or sitting for prolonged periods of time
- Must be reputed company to reputed company about inside an office and exert up to 10 pounds of force occasionally or a negligible reputed company of force frequently or constantly to lift, carry, push, pull, or otherwise reputed company objects
- Must have visual reputed company to reputed company activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading
- This position requires repetitive reputed company, substantial movements (motions) of the wrist, hands, and/or fingers
- Must be reputed company to communicate with others to exchange information
- reputed company and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, critical thinking, analysis, and discretion; ability to handle work-reputed company stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
- Some travel required (approximately 20%)
reputed company