Senior Specialist, QA IT Systems

Company 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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

The Sr Specialist QA IT Systems is responsible for providing direction in quality assurance software validation activities 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.

Responsibilities

• Provide validation support to project managers regarding activities supporting existing applications of all phases of the System Development Life Cycle process.
• Ensure software quality assurance is achieved during IT projects 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 validation projects.
• Manage all validation activities such as protocol writing, review of validation documents, storage of controlled documents and resolution to problem reports.
• Responsible for implementing Quality Control standards into departmental documents and ensuring all departmental training is complete.
• Provide direction to clients and software engineers regarding software validation/QA issues.
• Act as a liaison between IT department and other Quality 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 areas as possible: Chemistry, Pharmacy, Microbiology, Engineering and Computer Science. This should include a thorough technical knowledge of various aspects of the business including Quality Control/Assurance, GMP regulations, and new product development.
• Two years combined experience in software development and software testing desired, but not required.
• ASQ certification in Software Quality Engineering desired, but not required.

Additional Information

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

• Salary range may vary by country
• 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 an equal opportunity employer and 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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