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IT Compliance Consultant

Employer
AbbVie
Location
Lake County, IL, US
Start date
Aug 9, 2019

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

Software Quality Assurance ensures computer system software meets requirements and is validated throughout the system's and the drug development's life cycles. The functional group will ensure high quality products and data compliant with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11). We have a challenging opportunity for a Software Quality Engineer based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager.

Key responsibilities include:

  • Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements
    • Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate
  • Ensure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes and procedures
  • Establish quality system requirements for the Enterprise Systems
  • Provides project quality leadership for validation or SLC activities
  • Create and apply risk-based approach strategies effectively and efficiently without compromising compliance
  • Approve key project deliverables
  • Serves as expert resource with regards to the Enterprise Systems and compliance issues
  • Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
  • Lead process improvement projects


Basic:
  • 4 year college degree (preferably BS) in Computer Science, Engineering, Chemistry, Pharmacy, Biology, or Microbiology.

Preferred:
  • Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.

Key AbbVie Competencies:
  • Builds strong relationships with peers and cross functionally and with partners outside of the team.
  • Learns fast, grasps the "essence" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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