QA Specialist II

Position Title:

QA Specialist II

Number of Positions Needed: 1

Length of

Contract:

24 months

Location:

North Chicago, IL

Schedule:

3 days onsite, 2 days remote

• Maintenance, Configuration and Implementation of data for
  *** Market Authorization control system.
• Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.
• SAP S4/HANA and Track Wise experience preferred.
• Good verbal and written communication skills. Knowledge or experience in computerized system validation/testing.
• 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 with primary focus on review and approval of restrictions, configurations, and validation supporting documents.
• 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.
• Familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical and troubleshooting skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources.
• Support project teams in planning, preparation, reviewing and approval of quality documents. Create quality system documentation with guidance from technical teams following approved templates and guidelines.
• Collect and compile key quality metric data.
• Assist with processing configuration and restriction implementation within SAP S4/ HANA enterprise system.
• Maintain a high degree of accuracy and analytical thinking.
• Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and suggest improvements within the quality system.
• Assist in the design of effective quality systems, procedures and/or processes to ensure compliance as well as efficiency throughout the quality system.

Daily job responsibilities vary but overall:
Primary focus on creating, reviewing, and approving project deliverables, and compliance with applicable Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11. Responsible for complying with international regulatory requirements. Also, participate in various software lifecycle (SLC) deliverables reviews, risk analyses, troubleshooting business‑related issues and other quality assurance activities.

No travel required.

• SAP S4/Hana experience
• Quality Management systems experience including Document Management System
• Minimum Bachelor’s degree, background in software engineering or software quality assurance, Engineering or other technical/scientific area or equivalent experience.
• 4‑7 years experience

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.