Specialist / Senior Specialist - Quality Assurance
Kiniksa Pharmaceuticals
August 26, 2026
On-site
Lexington, MA
Operations
Responsibilities:
- Oversee quality operations at Kiniksa and external service providers (CDMOs/CTLs)
- Review and approve service providers’ GMP documentation
- Review and approve master/executed batch records and packaging records for drug substances and drug/finished drug products
- Perform GMP raw material release activities for internal manufacturing
- Review/approve laboratory data for release and stability, method qualification, and reference standards (protocols, data, reports)
- Collaborate with QA/RA/CMC and external providers to support timely document review/approval
- Review records including audit trails to ensure data integrity
- Support batch disposition (data upload, review, and documentation in applicable quality systems)
- Compile data for quality system reviews; evaluate/support GMP continuous improvement; other QA responsibilities as assigned
Skills For Impact:
- QA experience in a GMP-regulated environment
- Experience with Veeva QualityDocs and Veeva QMS
- Excellent verbal/written communication with internal and external providers
- Knowledge of current GMP (21 CFR Parts 210/211/Part 11) and EudraLex; other agency standards
Qualifications:
- BS in a scientific discipline; 4+ years in FDA-regulated pharma/biotech with GMP manufacturing operations, analytical development, and quality
- Experience reviewing GMP manufacturing records (batch records, change controls, deviations, investigations, product complaints) for clinical programs
- Hands-on lab testing and method validation
- Biologics/Combination Products experience (preferred)
- Familiarity with diverse test methods (plus); strong team orientation and solution-focused mindset
- Attention to detail; ability to work independently and collaboratively
Work location:
- Lexington, MA office; onsite five days per week
Pay Range:
- $107,500–$117,500 USD
- Oversee quality operations at Kiniksa and external service providers (CDMOs/CTLs)
- Review and approve service providers’ GMP documentation
- Review and approve master/executed batch records and packaging records for drug substances and drug/finished drug products
- Perform GMP raw material release activities for internal manufacturing
- Review/approve laboratory data for release and stability, method qualification, and reference standards (protocols, data, reports)
- Collaborate with QA/RA/CMC and external providers to support timely document review/approval
- Review records including audit trails to ensure data integrity
- Support batch disposition (data upload, review, and documentation in applicable quality systems)
- Compile data for quality system reviews; evaluate/support GMP continuous improvement; other QA responsibilities as assigned
Skills For Impact:
- QA experience in a GMP-regulated environment
- Experience with Veeva QualityDocs and Veeva QMS
- Excellent verbal/written communication with internal and external providers
- Knowledge of current GMP (21 CFR Parts 210/211/Part 11) and EudraLex; other agency standards
Qualifications:
- BS in a scientific discipline; 4+ years in FDA-regulated pharma/biotech with GMP manufacturing operations, analytical development, and quality
- Experience reviewing GMP manufacturing records (batch records, change controls, deviations, investigations, product complaints) for clinical programs
- Hands-on lab testing and method validation
- Biologics/Combination Products experience (preferred)
- Familiarity with diverse test methods (plus); strong team orientation and solution-focused mindset
- Attention to detail; ability to work independently and collaboratively
Work location:
- Lexington, MA office; onsite five days per week
Pay Range:
- $107,500–$117,500 USD