Cambridge Isotope Laboratories, Inc is hiring a
Quality Assurance Specialist I in United States

Summary

The job is for a Quality Assurance Specialist I at Cambridge Isotope Laboratories (CIL) in Tewksbury, MA. The role involves quality control of active pharmaceutical ingredients and medical device components. The employee will be responsible for various tasks such as batch record review, change management coordination, and GMP form reconciliation.

Requirements

• Bachelor Degree in Chemistry/Sciences or quality assurance/management; equivalent applicable industry experience may be substituted for the degree requirement
• Minimum of 5-8 years of experience in a GMP setting

Responsibilities

• Responsible for batch record review and release of finished products
• Assist as a change management coordinator (e.g. document change plans, equipment change plans, facility change plans, IT change plans)
• Authoring Annual Product Review Reports, as needed
• Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.)
• Responsible for periodic reconciliation of commercial API batch depletion
• Perform room/line clearances
• Label review and final inspections
• Create logbooks and controlled forms
• Perform GMP form reconciliation
• Report authoring
• Support other CIL organizations, as appropriate
• Perform any related work as required

Preferred Qualifications

Experience with Quality Assurance and knowledge and/or experience in ICH Q7, ISO 13485, is preferred

Benefits

• Competitive salary
• Comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible