QC / QA Documentation Associate
Location: On-site | Remote
Type: Full-time
About KELI Therapeutics
KELI Therapeutics is a European clinical-stage biotech company based in Kaunas, Lithuania, at the intersection of science, clinical translation, and global health. We are focused on treating high-burden inflammatory conditions with precision cell/gene and exosome-based therapeutics. Our pipeline includes mesenchymal stromal cells for systemic inflammation, chondrocyte-based products for orthopedic repair, and exosome formulations for the wellness and skincare markets. We operate under a licensed tissue establishment and GMP-ready manufacturing facility. We’ve launched a multicenter clinical trial for Acute Kidney Injury across five EU countries. We're scaling rapidly toward global commercialization, with strategic plans across Europe, the Gulf, Asia, and North America.
The Role
As a QC / QA Documentation Associate, you will maintain the records and documentation systems that support GMP batch release. You’ll work across multiple product lines, tracking deviations, CAPAs, and document readiness for inspections and audits.
This is a foundational quality role, ensuring every product release is backed by traceable, inspection-ready documentation.
Key Responsibilities
Manage GMP batch records across MSCs, chondrocytes, and exosomes
Track deviations and CAPAs in alignment with internal procedures
Maintain document control systems (SOPs, protocols, test records)
Coordinate with QC, QA, and production teams to ensure timely record updates
Support audit readiness and internal review processes
Assist with document formatting, version control, and archiving
What We’re Looking For
Degree in life sciences, quality management, or a related field
Experience with GMP documentation systems or regulated environments
Familiarity with deviation tracking, CAPA workflows, and document control
Detail-oriented and highly organized
Comfortable working in a fast-paced, regulated setting
What We Offer
Competitive salary (>1500 Eur Gross) based on experience and qualifications
Private health insurance
Personal time off
Relocation support
Flexible work hours where applicable
Annual training and professional development support
Travel opportunities to clinical sites and partner facilities
Work in a licensed, purpose-built GMP facility
Why Join Us
Join a growing company with global ambitions
Be part of a team developing therapies for unmet global medical needs
Work in a purpose-built GMP facility with cutting-edge cell technologies
Gain exposure to clinical-stage operations and international trials
Shape the future of regenerative medicine from the inside out
To Apply
Send your CV and a short cover note to global@keli.eu