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Quality & Compliance Specialist
Renovo Solutions. Monitor training assignments and due dates for Renovo and client-assigned personnel .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GxP compliance, quality assurance, and documentation practices, with a strong focus on training and qualification monitoring. Proficient in supporting audits and inspections while ensuring adherence to safety and regulatory standards.
Highest-signal resume keywords
GxP ComplianceGood Documentation PracticeTraining Compliance MonitoringAudit SupportCMMS Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceRegulatory AffairsDocumentation ReviewData IntegrityCorrective Action TrackingVendor QualificationCalibration Records ReviewProcess TrainingEvidence GatheringNon-Conformance Management
Soft Skills
CoachingCommunicationCollaborationProblem-SolvingAttention to Detail
Tools & Technologies
Computerized Maintenance Management System (CMMS)
Certifications & Qualifications
GxP TrainingOSHA Safety Training
Industry Keywords
PharmaceuticalBiotechnologyResearch EnvironmentGMPGLPGCPClient AuditsRegulatory InspectionsSafety RequirementsLaboratory Procedures
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Monitor training assignments and due dates for Renovo and client-assigned personnel
- Confirm personnel hold the correct training matrix for their role, site and asset scope
- Coordinate with clients and escalate overdue training
- Ensure no one performs work on GxP-critical assets without current qualification
- Maintain qualification evidence for assigned sites
- Report training and qualification gaps to the Manager, Quality and Compliance, and Site Operations Manager
- Support vendor qualification and requalification through evidence collection and file completeness checks
- Check representative samples of vendor work for required certifications and training
- Confirm approved vendor checklists and protocols are loaded before work is scheduled
- Review completed maintenance, calibration and repair records for compliance
- Verify good documentation practice, current procedures, and qualification status of instruments and standards
- Review GxP comments and follow up on deviations from standard procedures
- Correct documentation issues before closeout and coach record authors
- Review hardcopy calibration records held outside the system of record
- Raise and document non-conformances and coordinate quality events
- Support investigations through evidence gathering, record retrieval and timeline reconstruction
- Track corrective and preventive actions through closure
- Prepare assigned sites for client and regulatory audits and inspections
- Retrieve and assemble evidence during audit and inspection response
- Track audit findings and observations through closure
- Check documented processes against actual practice and flag discrepancies
- Support process-flow creation and maintenance
- Deliver process training and retraining to coordinators, engineers and analysts
- Support Master Data Analysts where record defects have compliance consequences
- Escort and host OEM and third-party personnel at client sites
- Confirm third-party induction, badging, safety and authorization requirements
- Verify authorized work and complete service records before third parties leave
- Escalate unannounced arrivals or unauthorized work
- Follow Renovo, customer-site, OSHA and laboratory safety requirements
Requirements
What you’ll need- 3+ years of experience in quality, compliance, regulatory affairs or a documentation review role in a GxP environment
- Demonstrated experience reviewing GxP records against good documentation practice
- Experience monitoring training and qualification compliance for a group of people
- Experience supporting client audits or regulatory inspections
- Working knowledge of good documentation practice, data integrity expectations, and GMP, GLP and GCP scope differences
- Experience with a computerized maintenance management system (CMMS) as a compliance record system
- Ability to correct a colleague’s record and coach them on it without damaging the working relationship
- Experience in a pharmaceutical, biotechnology or research environment required
- Associate or Bachelor’s degree preferred, in a scientific, technical or quality discipline
- Equivalent experience considered
- Training in GxP, data integrity, good documentation practice and client site safety provided or required
- Ability to wear required personal protective equipment when on site
- Ability to travel approximately 20 to 30 percent
- Follow applicable customer site safety requirements, OSHA guidelines, and laboratory or facility-specific procedures
- Complete required safety training assignments on time
Benefits
Comp & perks- Ongoing training
- Mentorship programs
- Supportive work environment
- Professional growth and advancement paths
- Training and retraining on Renovo and client processes
- Formal quality or compliance certification supported
- CMMS and platform training provided after hire
- Predominantly remote, office-based work
- Equal employment opportunities
- At-will employment