Quality Systems Specialist III

3 weeks ago


Chicago, Illinois, United States Abbvie Full time

Company Description

AbbVie is dedicated to discovering and delivering groundbreaking medicines and solutions to tackle serious health issues today and tomorrow's medical challenges. The goal is to make a significant impact on people's lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, as well as through products and services provided in the Allergan Aesthetics portfolio. Connect with AbbVie on social media platforms for more information.

Job Description

The Quality Systems Specialist III - Documentation plays a crucial role in ensuring compliance with AbbVie's documentation standards and principles. Responsibilities include managing the creation and revision of Quality System and processes documents, acting as a Subject Matter Expert for Quality documentation administration, and serving as a liaison between RDQA QS Documentation Management group and R&D functions.

Responsibilities:

  • Offer clients insights into AbbVie's Quality System and its practical application.
  • Participate in global compliance and continuous improvement projects related to Quality System documentation.
  • Ensure compliance during QS documentation creation and revision, overseeing content design and logistics of documentation review and approval.
  • Support the development of strategies for creating complex QS procedural documents involving cross-functional teams.
  • Ensure all administrative documentation requirements are met for Quality Documentation.
  • Facilitate the creation/revision, administration, review, and approval of new and revised Quality Documentation within the Document Management System (DM).
  • Maintain essential information within the Document Management System (DMS).
  • Participate in supporting R&D projects and initiatives related to documentation management.
  • Coordinate document translation processes when necessary.
  • Collect and analyze documentation-related key performance indicators.
  • Contribute to the overall team strategy and framework development for new initiatives.

Qualifications

Minimum Requirements:

  • Bachelor's Degree (Technical/Scientific Area preferred)
  • Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems
  • 1-2 years' experience using and administering electronic document management tools

Other Requirements:

  • Basic understanding and knowledge of GxP requirements and pharmaceutical regulations preferred.
  • Advanced proficiency with Document Management Systems and other database applications
  • Strong organizational skills and attention to detail
  • Experience with Microsoft Office products, incl MS Word processing / formatting
  • Excellent verbal and written communication skills
  • Ability to work effectively in a team environment and independently
  • Builds strong relationships with peers and cross-functional partners
  • Detailed oriented with strong problem-solving abilities

Additional Information

For applicants interested in this role, AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and participation in short-term incentive programs. AbbVie values integrity, innovation, diversity, and inclusivity in its operations and workforce.



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