Senior Specialist, QA IT Systems

3 weeks ago

North Chicago, United States AbbVie Full time
Job DescriptionJob DescriptionCompany Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Purpose

The Sr Specialist QA IT Systems is responsible for providing support of the development/configuration of Quality Lab software associated with the delivery of Lab-of-the-Future. In addition to supporting software development/configuration from business perspective this role will be instrumental in managing validation workflow for technology solutions provided including: reviewing software requirement documents; writing and reviewing validation documents; executing and reviewing validation test cases; and updating departmental procedures. This position ensures that defined software validation practices and procedures are being followed and that business requirements are being met.

Responsibilities

  • Work within project teams to ensure business requirements are understood and translated into applicable requirements documents as part of the SDLC process.
  • Ensure software quality assurance is achieved while meeting project objectives and deliverables; review validation deliverables to ensure consistency with defined practices and procedures.
  • May participate as a team lead or team member on Lab-of-the-Future digital workstream projects.
  • Manage one or more of the required validation activities such as requirement document/ protocol authoring, review of validation documents, storage of controlled documents and resolution to incident/exception reports.
  • Responsible for implementing Quality Control standards into departmental documents and ensuring all departmental training is complete.
  • Provide direction to business and IT stakeholders and project team members regarding software validation/QA issues.
  • Act as a liaison between IT department and other Quality Control/Assurance departments.
  • Interface directly with FDA and other regulatory agencies during audits.
  • Must complete project tasks within time and budget constraints.
Qualifications

Qualifications

  • Bachelor’s Degree in Science, Engineering or applicable discipline.
  • 5+ years’ experience in validation, systems testing, IT implementation, quality assurance or software quality engineering in a regulated healthcare industry.
  • Technical experience in as many of the following technical areas as possible: Chemistry, Microbiology, Laboratory Systems, and Computer Science. This should include a thorough technical knowledge of various aspects of the business including Quality Control/Assurance, GMP regulations, and software development lifecycle.
  • Two years combined experience in enterprise software configuration/support and testing.
  • Experience with Laboratory Enterprise Software systems (LIMS, Empower, LES/ELN, SDMS, SmartQC, and instrument integration solutions)
  • Demonstrated proficiency in authoring of quality system documents (Change Management, Risk Management, Validation lifecycle etc.)


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our short-term incentive programs. ​

​

Note: No amount of pay is a considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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