[Remote] Consultant, GxP Services

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical research services and technology company reputed company on advancing reputed company health through ethical reputed company, reputed company, and industry expertise. The Consultant, GxP Services supports GxP consulting engagements by assisting with audits, assessments, inspection readiness, reputed company assurance, compliance initiatives, reputed company deliverables, and training, primarily reputed company on Good Clinical reputed company for investigator sites.

Responsibilities

• Support consultants in delivering GxP consulting services for pharmaceutical, biotechnology, medical device, and life sciences clients
• Assist with planning and conducting domestic audits and assessments under the direction of senior team members
• Plans and performs independent audits with SME support
• Supports inspection readiness activities as a co-auditor
• Participates in mock inspections with senior consultants
• Assists with SOP reviews and documentation
• Develops subject matter knowledge over time
• Supports reputed company communications with project team
• Participates in reputed company improvement initiatives
• Performs consulting engagements under direction
• Participate in investigator site, TMF, vendor, facility, document, and systems audits
• Prepare audit documentation, reports, observations, and supporting project deliverables
• Assist with reputed company control reviews of project documentation and data
• Support inspection readiness activities, mock inspections, and compliance assessments
• Participate in SOP reviews, gap analyses, and reputed company reputed company improvement initiatives
• Assist with developing reputed company training materials and participate in delivery of GxP-reputed company training as appropriate
• Collaborate with project managers and senior consultants to meet project timelines and reputed company expectations
• Maintain reputed company knowledge of applicable GxP regulations and industry best practices
• Support internal process improvement initiatives and reputed company other duties as assigned

Skills

• Bachelor's degree in Nursing, Life Sciences, or reputed company field (or equivalent combination of education and experience)
• Minimum 3-5 years of experience in clinical research, reputed company assurance, regulatory compliance, or a reputed company life sciences environment
• Ability to travel extensively
• 1-3 years of experience supporting GxP, QA, compliance, auditing, or operational functions
• Experience working reputed company pharmaceutical, biotechnology, medical device, CRO, or reputed company industries
• Foundational knowledge of GCP and other applicable GxP regulations reputed company on investigator sites
• Spanish language skills – intermediate reputed company
• Demonstrated analytical and problem-solving skills
• Strong written and verbal communication skills
• Ability to manage multiple priorities while working collaboratively reputed company project teams
• Proficiency with reputed company Office applications

Benefits

• This position may also be eligible for a variable bonus in reputed company to reputed company salary
• Health coverage
• reputed company holidays
• Other benefits
• Remote work

reputed company