Senior Quality/Gxp Auditor

Requirements:

• B.S./B.A. in scientific discipline as a minimum.
• Minimum of 10 years of GxP auditing experience in related industry with a significant amount of time spent conducting CSV/SDLC auditing.
• Minimum of 14 years of experience within Pharmaceutical / Biotech / Medical Device industry.
• Excellent knowledge of GxP regulatory requirements.
• Demonstrated success in earning and maintaining a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team.
• Experience creating and working with high performance teams.
• Quality orientation and high attention to detail.
• Demonstrated ability to work with others and drive results.
• Ability to think ahead and prepare sound action plans to achieve results.
• Audit certification from reputable agency – required.
• Demonstrated Data Integrity (DI) Expertise – encouraged.
• Demonstrated Artificial Intelligence (AI) & Machine Learning Experience/Auditing - encouraged.
• Demonstrated GCP Auditing Experience - preferred.
• Required Skills and Abilities
• Capacity to make independent sound decisions and independently manage priorities.
• Ability to interact in a professional and positive manner with clients and co-workers.
• Exceptional communicator with strong persuasion skills and presentations.
• Excellent interpersonal and communication skills both written and verbal.
• Ability to write concise, accurate reports and other necessary documentation.
• Ability to provide and receive constructive feedback.
• Ability to organize and manage multiple projects.
• Excellent analytical skills and the ability to assess large quantities of information efficiently and effectively.
• Ability to read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.

Job Type: Contract

Experience level:

• 10 years

Schedule:

• Day shift

Work setting:

• Remote

Work Location: Remote