Senior QA Specialist – Onsite GMP Compliance & Release

Regulatory Jobs; Lexington (MA); On-site; USD 108,000 - 118,000; Full time

Job summary

Kiniksa Pharmaceuticals, based in Lexington, MA, is seeking a Specialist/Sr. Specialist, QA to provide QA support for manufacturing, QC, and analytical development, ensuring batch disposition and regulatory compliance.

This role requires onsite presence five days a week. Responsibilities include reviewing GMP documentation, batch records, regulatory data, and collaborating with CDMOs and internal teams to maintain data integrity and quality systems.

Qualifications

• 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.
• Bachelor's in a scientific discipline with 4+ years in the FDA regulated pharmaceutical/biotech industry with GMP manufacturing operations, analytical development and quality.
• Experience with Biologics and Combination Products (Cell and Gene Therapy, monoclonal antibodies) is preferred.

Responsibilities

• 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 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 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.

Skills

GMP-regulated experience

Veeva QualityDocs

Veeva QMS

Verbal & written communication

Regulatory standards knowledge

Education

Bachelor's degree in a scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

Job description

Kiniksa Pharmaceuticals, based in Lexington, MA, is seeking a Specialist/Sr. Specialist, QA to provide QA support for manufacturing, QC, and analytical development, ensuring batch disposition and regulatory compliance.

This role requires onsite presence five days a week. Responsibilities include reviewing GMP documentation, batch records, regulatory data, and collaborating with CDMOs and internal teams to maintain data integrity and quality systems.