Note: The job is a remote job and is open to candidates in USA. Advarra is a clinical research services and technology company focused on advancing human health through ethical review services, innovative solutions, and industry expertise. The Consultant, GxP Services supports GxP consulting engagements by assisting with audits, assessments, inspection readiness, quality assurance, compliance initiatives, client deliverables, and training, primarily focused on Good Clinical Practice 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 client communications with project team
- Participates in continuous 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 quality control reviews of project documentation and data
- Support inspection readiness activities, mock inspections, and compliance assessments
- Participate in SOP reviews, gap analyses, and quality system improvement initiatives
- Assist with developing client training materials and participate in delivery of GxP-related training as appropriate
- Collaborate with project managers and senior consultants to meet project timelines and client expectations
- Maintain current knowledge of applicable GxP regulations and industry best practices
- Support internal process improvement initiatives and perform other duties as assigned
Skills
- Bachelor's degree in Nursing, Life Sciences, or related field (or equivalent combination of education and experience)
- Minimum 3-5 years of experience in clinical research, quality assurance, regulatory compliance, or a related life sciences environment
- Ability to travel extensively
- 1-3 years of experience supporting GxP, QA, compliance, auditing, or operational functions
- Experience working within pharmaceutical, biotechnology, medical device, CRO, or related industries
- Foundational knowledge of GCP and other applicable GxP regulations focused on investigator sites
- Spanish language skills – intermediate fluency
- Demonstrated analytical and problem-solving skills
- Strong written and verbal communication skills
- Ability to manage multiple priorities while working collaboratively within project teams
- Proficiency with Microsoft Office applications
Benefits
- This position may also be eligible for a variable bonus in addition to base salary
- Health coverage
- Paid holidays
- Other benefits
- Remote work
Company Overview