Associate Specialist, Quality Systems

AbbVie•North Chicago, IL

2d•$58,656 - $103,500

About The Position

The Associate Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Requirements

Bachelor’s Degree (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred) or equivalent experience.
0-2 years’ experience in quality assurance, quality oversight or relevant experience.
Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological and medical device products preferred.
Strong oral and written communication skills needed.
Excellent interpersonal skills a plus.
Delivers tactical results to support the quality system.

Responsibilities

Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
Perform quality review of quality system and computerized system changes.
Perform quality review of specifications associated with drug, biologics, device and/or combination products.
Complete and route change requests for process document creation, maintenance, and implementation.
Support project teams in planning, preparation, review and approval of quality documentation.
Collect and compile key quality metric data.
Participate in training and education programs for various aspects of quality assurance.