Compliance Specialist, Quality Assurance - QA​/QC

Job Description

• Review of Quality Critical Alarms and NRSR
• Review J&Cs
• Initiate and investigate deviations for non-conformance
• Provide off-hour support for batch record issuance
• Function as back-up for QA Manager
• Other activities as assigned

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

• Bachelor’s Degree in a scientific field and 4-6 years experience in a Quality and /or other cGMP related field,
• or Master’s Degree in a scientific field and 2 years’ experience in above.
• 2 years of experience in a Quality role.
• Knowledge in external agency regulations (FDA, EMA, etc.)
• Strong computer, verbal and written communication skills.
• Experience in quality systems.
• Experience in leading cross functional team.
• Experience with Track wise or equivalent system.
• Proficient in Microsoft Office.

All your information will be kept confidential according to EEO guidelines.