QA Specialist - GLP/GCP Bioanalysis & Data Integrity

MEDICILON USA CORP; Lexington (MA); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

Medicilon USA CORP is establishing a Bioanalysis Center of Excellence in Lexington, MA to support GLP preclinical and GCP/GCLP clinical bioanalysis across LC-MS/MS, immunoassays, PCR/qPCR/ddPCR, flow cytometry, and related technologies.

We are seeking an experienced Quality Assurance Specialist to build an independent QA function, develop quality systems, ensure regulatory compliance, maintain data integrity, and support audit readiness across studies and vendor activities.

Competenze

• Requires hands-on QA experience in a regulated laboratory, pharma, biotech, CRO environment.
• Experience developing and maintaining Quality Management Systems (QMS).
• Knowledge of GLP, GCP/GCLP, and data integrity principles.

Mansioni

• Establish, implement, and maintain a QMS supporting GLP preclinical and GCP/GCLP bioanalytical operations.
• Develop and maintain SOPs, document control, training records, deviations, CAPA, and change control processes.
• Audit and inspect studies, lab operations, facilities, equipment, systems, and study documentation.

Conoscenze

Quality Assurance

GxP Compliance

Audits & Inspections

SOP Writing

Data Integrity

Regulatory Knowledge

Analytical Skills

Formazione

Bachelor's degree in life sciences or related

Strumenti

QMS software

CAPA system

Document control systems

Descrizione del lavoro

Medicilon USA CORP is establishing a Bioanalysis Center of Excellence in Lexington, MA to support GLP preclinical and GCP/GCLP clinical bioanalysis across LC-MS/MS, immunoassays, PCR/qPCR/ddPCR, flow cytometry, and related technologies.

We are seeking an experienced Quality Assurance Specialist to build an independent QA function, develop quality systems, ensure regulatory compliance, maintain data integrity, and support audit readiness across studies and vendor activities.