Specialist / Senior Specialist - Quality Assurance

Responsibilities (including, but not limited to):

• Oversee quality operations at Kiniksa and at external service providers (CDMO’s/CTL’s)


• Review and approve service provider’s GMP documentation


• Review and approve master/executed batch records, packaging records for, drug substances, drug product/finished drug product


• Perform GMP raw material release activities for Kiniksa internal manufacturing operations


• Review and approve laboratory data related to release and stability of GMP materials, qualification of test methods and reference standards, including protocols, data and reports


• Collaborate with external service providers and internally with QA, RA, CMC teams to support the timely review and approval of documents


• Review records including audit trails and ensure integrity of data and results generated by Kiniksa and external CDMO’s/CTL’s


• Support batch disposition activities, including data upload, review, and documentation in applicable quality systems


• Compile data for Quality system reviews


• Evaluate and support GMP activities for continuous improvement


• Other Quality Assurance responsibilities as assigned

Standout Skills for Impact:

• QA experience in a GMP-regulated environment


• Experience with Veeva QualityDocs and Veeva QMS


• Excellent verbal and written communication skills with proven track record of communication with internal and external service providers


• Knowledge of industry standards, current GMP (21CFR Parts 210 & 211 & Part 11 and EudraLex) and other agency standards

Qualifications and Experience:

• Bachelors in a scientific discipline with 4+ years of experience in the FDA regulated pharmaceutical/biotech industry with GMP manufacturing operations analytical development and quality


• Experience in Biologics and Combination Products (Cell and Gene Therapy, monoclonal antibodies) is preferred


• Experience with review of GMP manufacturing records (Master/Executed batch records, change controls, deviations, investigations, change controls, product complaints) associated with clinical programs


• Hands-on experience with laboratory testing and method validation


• Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as cell banks, drug substance, drug product, and combination products is a plus


• Strong team player that has a customer service approach and is solution oriented


• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external service providers in a professional and collaborative manner