QA Specialist – GLP/GCP Bioanalysis & Data Integrity

MEDICILON USA CORP; Lexington (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Medicilon USA Corp is establishing a Bioanalysis Center of Excellence in Lexington, MA and seeks an experienced Quality Assurance Specialist to build and maintain QA systems for GLP preclinical and GCP/GCLP operations. The role requires ensuring regulatory compliance, data integrity, and audit readiness across LC-MS/MS, immunoassays, PCR/qPCR, and related technologies.

The ideal candidate has hands-on QA experience in regulated labs and CRO settings, with detail orientation, initiative, and

Qualifications

• 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 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 bioanalytical laboratory operations, method validation, and computerized laboratory systems.

Responsibilities

• Establish, implement, and maintain a QMS supporting GLP preclinical and GCP/GCLP clinical bioanalytical operations.
• Develop and maintain SOPs, document control, training records, deviations, CAPA, and change control processes.
• Audit studies, lab operations, facilities, equipment, systems, and study documentation.
• Provide QA oversight for method validation, transfer, data integrity, and study records.

Skills

QA experience

Regulatory knowledge

Audits & CAPA

Data integrity

SOP management

Analytical skills

Communication skills

Education

Bachelor's degree in life sciences or related field

Job description

Medicilon USA Corp is establishing a Bioanalysis Center of Excellence in Lexington, MA and seeks an experienced Quality Assurance Specialist to build and maintain QA systems for GLP preclinical and GCP/GCLP operations. The role requires ensuring regulatory compliance, data integrity, and audit readiness across LC-MS/MS, immunoassays, PCR/qPCR, and related technologies.

The ideal candidate has hands-on QA experience in regulated labs and CRO settings, with detail orientation, initiative, and