Overview
Senior Quality Assurance Consultant Jobs in Santa Rosa, California, USA at Lumicity
Client: Biotechnology Company
Project Details:
6-Month contract with full-time commitment.
40 hours per week.
Bi-weekly on-site presence required.
Key Responsibilities:
Oversee quality standards of outsourced GMP operations including CMC, CDMO, and contract labs.
Review, approve, or reject critical documentation such as policies, batch records, test methods, and change controls.
Conduct lot disposition for drug substances, products, and clinical materials.
Support the investigation of deviations and CAPAs to ensure regulatory compliance.
Assist with regulatory audits and vendor qualifications to maintain high-quality standards.
Present quality metrics and lead initiatives for continuous improvement.
Requirements:
Bachelor’s degree in molecular biology, biochemistry, or a related field;
Master’s degree preferred.
At least 10 years of QA management experience in biotechnology or medical devices.
In-depth knowledge of cGMPs, FDA regulations, and international standards.
Outstanding communication, organizational, and mentoring skills.
Title: Senior Quality Assurance Consultant
Company: Lumicity
Location: Santa Rosa, California, USA
Category: Healthcare (Medical Science, Data Scientist), Quality Assurance – QA/QC
