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Precise Solutions Software Quality Assurance Engineer in Waukegan, Illinois

Precise Solutions is an Illinois BEP/FBE (female owned business enterprise) certified consulting company founded in 2000. Our mission is to provide companies with specialized resources that can drive their system portfolio projects using program management processes, change management and blended learning solutions. Please visit our website at www.precise-solutions.com

At Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the pharmaceutical and healthcare industries primarily located in the Northern Chicago Suburbs. We are much more than a consulting firm! Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and 401k. We currently have an immediate need for the following:

Senior Software Quality Assurance- GxP

RESPONSIBILITIES:

  • The candidate is responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.

  • Lead or participate in various reviews, risk analyses and other software quality assurance activities.

  • Have a background in software engineering, software lifecycle activities, or software validation and be familiar with the work products that result from SLC key activities.

  • Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.

  • The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment.

  • Analytical skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources. Good with verbal and written communication skills.

REQUIRED:

  • Minimum Bachelors degree, background in software engineering or software quality assurance.

  • Hands-on professional with experience in the software lifecycle (SLC)

  • Must be able to work 50 weeks out of the year, excluding Client holidays.

HIRING MANAGER?S NOTES: Daily job responsibilities they vary but overall:

  • Review and approve computerized system deliverables for compliance with this process and quality standards

  • Ensure that deliverables for the GxP are compliant with applicable policies, processes, and procedures

  • Provide subject matter expertise on GxP regulatory requirements

  • Experience working with software lifecycle deliverables and ability to incorporate updates to meet the needs of the business and project teams;

  • Effective time management and ability to adjust workload to meet customer needs;

  • Excellent interpersonal skills with the ability to work collaboratively with multiple project teams of differing backgrounds

  • Must be able to work 50 weeks out of the year, excluding Client holiday

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