Overview
Sr. Quality Assurance Specialist Jobs in Greater Boston at Harba Solutions Inc.
Title: Sr. Quality Assurance Specialist
Company: Harba Solutions Inc.
Location: Greater Boston
Job Responsibilities
Provide active support for QC site operations, including facilities, laboratory, and IT operations.
Collaborate with QC and support teams to ensure compliance with quality systems and regulatory requirements.
Review and approve analytical method validation protocols, reports, and data packages.
Generate and approve Certificates of Analysis (COAs) in LIMS for batch release and regulatory filings.
Oversee Analytical QA approvals for deviations and change controls.
Support inspection readiness programs and participate in audits as needed.
Provide quality system guidance for QC laboratories, ensuring robust data review processes.
Apply risk management principles to drive continuous improvements in QC-related procedures.
Qualifications
Bachelor’s degree in microbiology, chemistry, biochemistry, or a related field.
Minimum of 6-8 years of Quality Assurance experience in a GMP-regulated biopharmaceutical or biotechnology environment, with a focus on Quality Control.
Familiarity with both internal QC operations and external contract testing laboratories is preferred.
Strong understanding of FDA and EMA regulations, with experience supporting regulatory agency inspections.
Proven experience in leading continuous improvement initiatives within a quality-focused environment.
The Company
Join a cutting-edge biopharmaceutical company driving innovation in innovative biologic treatments! This fast-growing organization is revolutionizing patient care through advanced therapies, including gene therapy and biologics. With a strong pipeline, global expansion, and a mission-driven culture, this is an opportunity to make a real impact while advancing your career in a dynamic, science-focused environment. If you’re passionate about innovation and looking to grow in a company that values collaboration and breakthrough thinking, let’s connect!
