Quality Systems Associate Specialist

AbbVie • North Chicago, IL

1d

About The Position

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

Requirements

• At least 3 years of experience in quality assurance, quality oversight, or relevant work.
• Technical knowledge in as many as possible of the following areas: Quality, Regulatory, Process Sciences, and Manufacturing Operations.
• Experience working both in a team setting and independently.
• Ability to work with manager guidance to complete tactical objectives while managing time effectively.
• Strong oral and written communication skills.

Nice To Haves

• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or another technical or scientific area.
• Familiarity with products, processes, equipment, and facilities related to pharmaceutical, biological, or device products.
• Knowledge of quality assurance systems and GMP compliance requirements, including regulations and standards affecting device, biologics, and pharmaceutical products.
• Excellent interpersonal skills.

Responsibilities

• Assist with the integration and support of quality regulations for drugs, biologics, devices, and/or combination products.
• Assist project teams with planning, preparing, reviewing, and approving quality documentation.
• Complete and route change requests for creating, maintaining, and implementing process documents.
• 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 cross-functional teams in designing effective quality systems, procedures, and processes that support compliance and efficiency.
• Assess compliance with processes and regulations, identify potential gaps, and mitigate them by implementing improvements within the quality system.
• Participate in training and education programs covering aspects of quality assurance.
• Run small projects to deliver tactical results.

Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) for eligible employees.
• Eligibility to participate in short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level