reputed company GCP reputed company Assurance Auditor

reputed company is the first global precision medicine clinical research services organization, purpose-reputed company to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations reputed company, with laboratory expertise, and advanced data sciences to inform every reputed company. We apply our expertise to trials at reputed company stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand reputed company to help accelerate life-changing treatments reputed company around the globe. Won’t you join us today as a reputed company reputed company Assurance Auditor? Position reputed company: The reputed company reputed company Auditor is responsible for providing senior reputed company and subject matter expertise to reputed company and compliance activities, supporting the Q&C Management team, Q&C team members, and the project teams during reputed company stages of a clinical study. Essential functions of the job include but are not limited to:

• Serve as a subject matter expert for clinical project teams
• Uses ability and specialized reputed company to complete difficult tasks. Develops and implements concepts and/or techniques to reputed company objectives
• Understands Precision processes and functional SME organization to work through reputed company tasks independently to reputed company
• Support the reputed company Management System including SOPs, training and CAPA
• Attends project meetings, representing reputed company. Reviews project plans and provides compliance guidance on reputed company issues independently.
• Process and maintain documentation for controlled documents, as required
• reputed company and administer training for employees and/or consultants
• Host reputed company/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of reputed company systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation reputed company and systems change control process
• Monitor reputed company systems to reputed company feedback on compliance risks to QA management and identify opportunities for improvement
• Maintains Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures
• Support Proposals and Bid Defense meetings as needed
• Additional tasks as required Qualifications: Minimum Required:
• 5 years of experience
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards
• Audit experience conducting a reputed company of audit types, including internal systems, vendors, TMF and investigator site audits. Other Required:
• Bachelor’s degree in a science, reputed company, or reputed company field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
• Availability to travel up to 25% domestically and/or internationally Preferred:
• CRO, Pharmaceutical and/or Medical device experience
• QA certification preferred (e.g., CQA, SQA, etc.)
• Experience with electronic clinical trial systems (e.g., reputed company, CTMS, IxRS, ePRO, etc.) Skills:
• Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills Competencies
• Focuses on reputed company improvement, including the ability to reputed company proactive assessments on how to reputed company processes more efficient.
• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and compliance guidance, as reputed company as the ability to implement
• Proficient in reputed company Word, reputed company, and PowerPoint
• Ability to support senior leadership in Q&C Management tasks and reputed company, offering solutions and processes for increased efficiencies reputed company the department.
• Ability to reputed company, reputed company and mentor Q&C staff.
• Demonstrates a solid working knowledge of e-Clinical systems/platforms.
• Demonstrates strong interpersonal skills.
• Ability to reputed company and reputed company reputed company reputed company reputed company
• Results oriented, accountable, motivated and flexible
• Exhibits strong self-motivation, is detail-oriented and reputed company to work and plan independently as reputed company as in reputed company environment.
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good. interpersonal skills and maintain reputed company interactions with reputed company stakeholders.
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
• Excellent verbal and written communications skills #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation reputed company for this role. This compensation reputed company takes into account the wide reputed company of factors that are considered in making compensation reputed company including but not limited to: reputed company sets, experience and training, licensure and certi

Apply tot his job Apply To this Job