Job Description :
Job Title: Senior Software Quality Analyst
Duration: 3-4 months on W2
Location: Waukegan, IL 60085
Job Description
Candidate must have worked in a regulated environment previously.
Primary Job Function
Primarily responsible for basic level quality assignments, for example, reviewing/auditing, and authoring project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements. This role assists with activity supporting the QA System and business driven objectives. In addition to these primary areas of focus, quality assurance will assist with project work related to:
Infrastructure (Hardware or Layered Software Installations)
Application quality
Compliance initiatives
Validations
Internal / supplier audits
CAPA system investigation, confirmation, or verification.
Job Responsibilities
1. Accountable for supporting project documentation for the software development lifecycle (SDLC for quality and non-quality applications.
2. Supports projects by:
a. Reviewing test data and supporting validation documentation
b. Assisting with system design to help design in quality to systems
c. determining validation strategies based on system design.
d. Creating protocols to challenge system functionality
e. Coordinate final package submission to QA library or other library projects as necessary
f. Providing administration for validation review board meetings.
3. Responsible for recognizing and elevating sensitive quality and regulatory issues for applications, layered software, & hardware.
4. Recognize gaps in project documentation and recommend modification to the quality and non-quality systems.
5. Assist in developing and maintaining written policies, processes, and procedures related to the quality system.
6 Assist in providing training and/ or training material related to the QA Program.
Accountability
Responsible for ensuring that Corporate and Divisional systems (applications, layered software, & hardware) are compliant to Abbott internal, FDA, and other regulatory requirements. The absence of consistent implementation and enforcement of compliance could lead to regulatory action. Financial penalties to the corporation or division(s) are possible consequences.
Education
Bachelor’s Degree, Science, IT, Business or Engineering
Experience and Training
Experience in a formal software development life cycle (minimum 5 years Experience in regulated software environment. (minimum 3 years) Software Quality experience (Minimum 3 years), Must be familiar with applicable US regulations (GMP parts 11, 58, 210, 211, and 820
Experiences that are considered a plus:
Project Management
Auditing Experience
Quality Systems experience