Compliance Specialist, Quality Assurance - QA​/QC

We are a next-generation digital transformation, technology consulting, enterprise IT, and product engineering services firm.

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.

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

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