QA IT Systems Senior Specialist (Remote)

Thecentermemphis; Illinois; Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Sr Specialist in QA IT Systems to lead quality assurance software validation efforts. This role involves ensuring compliance with industry standards throughout the System Development Life Cycle while collaborating with project managers and regulatory agencies. You will play a crucial role in maintaining software quality, managing validation activities, and providing direction to clients and engineers. If you have a passion for quality assurance and a strong background in regulated environments, this opportunity offers a chance to make a significant impact on healthcare solutions.

Benefits

Paid Time Off

Medical/Dental/Vision Insurance

401(k) Plan

Short-term Incentive Programs

Qualifications

• 5+ years in validation and quality assurance in a regulated healthcare environment.
• Technical knowledge in Chemistry, Pharmacy, Microbiology, and Engineering.

Responsibilities

• Provide validation support and ensure software quality during IT projects.
• Manage validation activities and ensure compliance with QA standards.

Skills

Quality Assurance

Software Validation

Regulated Healthcare Industry

Systems Testing

Project Management

Education

Bachelor’s Degree in Science

Engineering Degree

Job description

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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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

• 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:

• 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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html