AbbVie

Specialist, Quality Systems

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Feb 27, 2021
Ref
2102867
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The 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.

This role is also responsible for compliance with the US FDA CFR regulatory requirements for Prescription Drug Marketing Act (PDMA), Good Distribution Practices (GDP), Advertising and Promotional Material, as well as AbbVie policies and procedures. Mange and report PDMA events to the FDA per requirements, and manage associated documentation, tracking, follow-up activities, and metrics.

US Commercial Quality works collaboratively with Sample Operations, vendors, Medical Review, Regulatory, Commercial Operations, OEC, Legal, and other cross functional areas.

  • 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.
  • Grade level is to commensurate with overall experience

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 setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Strong oral and written communication skills needed.
  • Excellent interpersonal skills a plus.
  • Runs small projects to deliver tactical results.

Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.