Quality Systems Associate Specialist

AbbVie•North Chicago, IL

2d•$65,500 - $125,500

About The Position

The Quality Systems Associate Specialist provides quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products, and biologics. Areas of support may include the Document Center, Device QA, Labeling, Validation, Training, and CAPA. The role ensures that product-, process-, and system-related quality activities—from raw material inspection through shipment of final product—comply with corporate and governmental regulations.

Requirements

At least 3 years of experience in quality assurance, quality oversight, or relevant experience.
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, and Manufacturing Operations.
Experience working both in a team setting and independently; able to complete tactical objectives with manager guidance and manage time effectively.
Strong oral and written communication skills.
Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or another technical/scientific area is preferred.

Nice To Haves

Knowledge of and familiarity with products, processes, equipment, and facilities related to pharmaceutical, biological, or device products.
Knowledge of QA systems and GMP compliance requirements, including regulations and standards affecting device, biologics, and pharmaceutical products.
Excellent interpersonal skills.

Responsibilities

Assist with the proper integration and support of quality regulations for drugs, biologics, devices, and/or combination products.
Assist project teams with planning, preparation, review, and approval of quality documentation.
Complete and route change requests for process document creation, maintenance, and implementation.
Create quality system documentation and specifications with guidance from technical teams, using approved templates and guidelines.
Assist with or co-lead audits of documentation, facilities, and equipment.
Assist in designing effective quality systems, procedures, and/or processes within cross-functional teams to support compliance and efficiency.
Assess compliance with processes and regulations, identify potential gaps, and mitigate issues and implement improvements within the quality system.
Participate in training and education programs covering various aspects of quality assurance.
Run small projects to deliver tactical results.