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Quality Assurance

Orbis Clinical has the quality assurance expertise to assist life sciences organizations with their highly regulated products, and ensure compliance with good clinical practices. Our life sciences and biotech quality control consultants provide world-class QC support across all facets of research and development, from preclinical to post-market.

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Audit Expertise in Biotech Quality Assurance and Quality Control

Internal and external, domestic and international GxP auditing:

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GMP

  • Good Manufacturing Facilities
  • API/Drug Product/Sterile Product, Manufacturing
  • Excipient/Raw Material, Analytical Lab
  • Micro, Stability, Release, Clinical Packaging/Distribution

GCP/GLP/GCLP/GVP

Good Clinical Practices / Good Laboratory Practices / Good Clinical Laboratory Practices / Good Pharmacovigilance Practices

  • CROs, Investigators, Monitors, Suppliers & Study Sites
  • Contract, QC, Central, Specialty & Analytical Laboratories
  • Safety Reporting, PV Audits, Software Vendor

Licensing

  • Partners
  • Agreement

Quality Assurance Jobs We Staff

  • Quality Assurance, Quality Control and Quality Systems Subject Matter Expertise
  • Remediation, Site Readiness Assurance, Batch Record Review, Document Control, ISO Compliance
  • CAPAs and Quality Management Plans, FDA 483 Response Preparation and Review, SOP Development and Review
  • Policy Development, Validation Guidelines, Validation Plans, Test Plans and Procedures, Project Management

What people are saying about Orbis Clinical

Great team to work with. Orbis team cares about the need of the employees every step of the way not just at the start.
Archana M.Google
Myles was my recruiter contact Orbis and he was great ever since he brought this opportunity. He was well informed of the role and exlplained and understood how my experience pertains to the role. He was very responsive and always ready to answer any questions I had.
Clinical Study SpecialistGlassdoor
Professional, Friendly, Supportive, Consistent, Responsive, Follows up and doesn’t leaving you hanging!
Manager, Quality ManagementGlassdoor

Ready to Strengthen Your QA Team?

Talk to our team about your quality assurance staffing needs, or call us at (781) 328-1132.

Discuss Your QA Needs