Quality Assurance Specialist

Medicilon USA is establishing a Bioanalysis Center of Excellence in Lexington Massachusetts supporting 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 help establish and maintain an independent quality assurance function for our growing bioanalytical operations. This individual will play a key role in developing quality systems ensuring regulatory compliance maintaining data integrity and supporting audit and inspection readiness.

The ideal candidate has hands-on QA experience in a regulated laboratory pharmaceutical biotechnology or CRO environment. We are looking for someone who is detail-oriented proactive and comfortable building quality processes in a growing organization while collaborating closely with scientific and operational teams.

Key Responsibilities

Quality Management Systems & Compliance

• Establish implement and maintain a Quality Management System (QMS) supporting GLP preclinical and GCP/GCLP clinical bioanalytical operations.
• Develop and maintain standard operating procedures (SOPs) document control training records deviations corrective and preventive actions (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 strengthen quality systems and laboratory processes.

Quality Assurance Oversight & Auditing

• 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.

Laboratory Quality & Data Integrity

• 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.

Audit & Inspection Readiness

• Coordinate and support sponsor audits customer quality assessments and regulatory inspections including FDA Bioresearch Monitoring (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.

Cross-Functional Collaboration

• Partner with scientific leadership laboratory personnel and management to promote a strong culture of quality and compliance.
• Provide quality-related training and guidance to laboratory and operational teams.
• Maintain appropriate independence from laboratory operations with direct access to senior management for significant quality and compliance concerns.

Qualifications

• Bachelors degree in life sciences chemistry biochemistry pharmaceutical sciences or a related field.
• Minimum 23 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.

Preferred Qualifications

• 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.

Medicilon USA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability veteran status or any other characteristic protected by law.