Specialist / Senior Specialist - Quality Assurance

The Specialist/Sr. Specialist, QA is recognized as a subject matter expert in the application of quality assurance and compliance. The incumbent will provide QA support for internal/external manufacturing and laboratory operations, quality control, analytical development in support of batch disposition activities. The incumbent will perform review of drug substance/drug product/finished drug product manufacturing records and associated documents (e.g. Deviations, change controls, investigations, supplier change notifications) for products that will be released for use in Kiniksa programs.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

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