Quality Engineer

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience, and products and services in our Allergan Aesthetics portfolio.

About the role

The Quality Engineer 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 ensures 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.

Responsibilities

• Assist with proper integration and support of quality regulations: drug, biologics, device, and/or combination products.
• Assist project teams in 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 following approved templates and guidelines.
• Assist with or co-lead audits of documentation, facilities, and equipment.
• Assist in the design of effective quality systems, procedures, and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality system.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Participate in training and education programs for various aspects of quality assurance.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area preferred.
• 3+ years’ experience in quality assurance, quality oversight, or relevant experience.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological, or device-related products preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Experience working in both team settings and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Strong oral and written communication skills.
• Excellent interpersonal skills a plus.
• Runs small projects to deliver tactical results.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.