Quality Assurance Specialist - GCP/GLP

Cb•Lexington, MA

About The Position

Medicilon USA is establishing a Bioanalysis Center of Excellence in Lexington, Massachusetts, to support GLP preclinical and GCP/GCLP clinical bioanalysis across LC-MS/MS, immunoassays, PCR/qPCR/ddPCR, flow cytometry, and related technologies. The Quality Assurance Specialist will help establish and maintain an independent quality assurance function for growing bioanalytical operations. The role supports development of quality systems, regulatory compliance, data integrity, and audit and inspection readiness. The position calls for hands-on QA experience in a regulated laboratory, pharmaceutical, biotechnology, or CRO environment, with the ability to build quality processes and collaborate with scientific and operational teams. The specialist will establish and maintain a Quality Management System, develop and manage quality documentation and processes, conduct risk-based audits, and provide QA oversight for bioanalytical work and laboratory systems. The role also supports sponsor audits, customer quality assessments, and regulatory inspections, and works with laboratory and management teams to promote a culture of quality. The position maintains appropriate independence from laboratory operations and has direct access to senior management for significant quality and compliance concerns.

Requirements

Bachelor's degree in life sciences, chemistry, biochemistry, pharmaceutical sciences, or a related field.
Minimum 2–3 years of quality assurance experience in a regulated laboratory, pharmaceutical, biotechnology, CRO, or bioanalytical environment.
Experience supporting GLP, GCP/GCLP, and/or regulated bioanalytical operations.
Working knowledge of applicable regulatory requirements, including ICH M10, ICH E6(R3), 21 CFR Part 11, 21 CFR Part 58, and data integrity principles.
Experience with quality audits, deviations, CAPA, SOP management, and quality documentation.
Understanding of bioanalytical laboratory operations, method validation, and computerized laboratory systems.
Strong organizational, analytical, communication, and problem-solving skills.
Ability to work independently, manage competing priorities, and collaborate effectively across teams.

Nice To Haves

Experience establishing or improving a QMS in a growing laboratory or CRO environment.
Experience with bioanalytical platforms such as LC-MS/MS, ligand-binding assays, PCR/qPCR, or flow cytometry.
Experience with computerized system validation, sponsor audits, or regulatory inspections.
RQAP-GLP, RQAP-GCP, or other relevant quality certification.

Responsibilities

Establish, implement, and maintain a Quality Management System supporting GLP preclinical and GCP/GCLP clinical bioanalytical operations.
Develop and maintain SOPs, document control, training records, deviations, CAPA, and change control processes.
Support compliance with applicable regulatory requirements and industry standards, including ICH M10, ICH E6(R3), 21 CFR Part 11, 21 CFR Part 58, and ALCOA+ data integrity principles.
Identify compliance risks and recommend practical improvements to quality systems and laboratory processes.
Conduct independent, risk-based audits and inspections of studies, laboratory operations, facilities, equipment, computerized systems, and study documentation.
Provide QA oversight for bioanalytical method validation, method transfer, sample analysis, data integrity, and study records.
Review deviations, investigations, CAPA effectiveness, and quality-related documentation.
Support qualification and oversight of vendors, subcontractors, and external service providers.
Support computerized system validation, equipment qualification, calibration, and environmental monitoring programs.
Ensure appropriate documentation, traceability, and integrity of laboratory data and electronic records.
Work with laboratory teams to identify quality gaps, resolve compliance issues, and implement process improvements.
Coordinate and support sponsor audits, customer quality assessments, and regulatory inspections, including FDA BIMO inspections.
Maintain inspection-ready documentation and assist with audit responses, corrective actions, and follow-up activities.
Monitor quality metrics and provide regular updates on compliance risks, audit findings, and quality improvement initiatives.
Partner with scientific leadership, laboratory personnel, and management to promote a culture of quality and compliance.
Provide quality-related training and guidance to laboratory and operational teams.
Maintain appropriate independence from laboratory operations and direct access to senior management for significant quality and compliance concerns.