Covance IT Software Quality Analyst (SQA) in Indianapolis, Indiana

Job Description:

The IT Software Quality Assurance (SQA) Analyst is accountable for IT software testing activities in under FDA and CLS Division regulations and procedures. The SQA Analyst will provide services for IT testing and software validation initiatives. The SQA Analyst will liaise with Management to execute the Company’s overall IT software testing strategy by executing computer systems testing activities. The SQA Analyst will work / interact regularly with Project Managers, Business Systems Analysts, Developers, Validation Engineers, as well as respective members from Internal Audit, IT QA, Business Unit QA, IT Operations and IT Architecture organizations. The SQA Analyst will apply a holistic approach that covers GxP and non-GxP applications to enhance testing outcomes through a defined methodology.

• Own and execute a risk based validation methodology as related to a harmonized SDLC.

• Enforce Covance standard testing methodologies, procedures, and practices as they relate to systems validation.

• Participate in resource related activities associated with the team, including demand management, on-boarding and training of staff and partner vendor resources.

• Participate in process related activities associated with the team, test planning, script development, test execution (e.g., Reporting, Metrics), success criteria and measurement, and SOPs to reflect change in roles and responsibilities.

• Learn and use a common set of tools for conducting computer testing, and manage the use of tools associated with testing activities, including HP ALM / Quality Center (Testing Tool).

• Recommend proper testing controls for the BU computer systems to ensure the reliability of applications, as well as the integrity of data and safety of subjects.

• Assure that IT applications components possess the necessary level of testing, and required documentation to comply with applicable GXP regulations and customer requirements/expectations.

• Execute technology, standards, and processes in accordance with department objectives and goals.

• Prepare test models for testing initiatives, and present to project teams.

• Participate with the IT Compliance Audit function in the execution of the continuous improvement model of the Company’s testing methodology and SDLC.

• Partner with Corporate, business unit QA, and IT Compliance Audit functions to assess and leverage supplier information for testing activities.

Requisition ID: 69568BR

Job Category: Information Technology

Locations: United States - Indianapolis, IN

Shift: 1

Job Postings: The IT Software Quality Assurance (SQA) Analyst is accountable for IT software testing activities in under FDA and CLS Division regulations and procedures. The SQA Analyst will provide services for IT testing and software validation initiatives. The SQA Analyst will liaise with Management to execute the Company’s overall IT software testing strategy by executing computer systems testing activities. The SQA Analyst will work / interact regularly with Project Managers, Business Systems Analysts, Developers, Validation Engineers, as well as respective members from Internal Audit, IT QA, Business Unit QA, IT Operations and IT Architecture organizations. The SQA Analyst will apply a holistic approach that covers GxP and non-GxP applications to enhance testing outcomes through a defined methodology.

• Own and execute a risk based validation methodology as related to a harmonized SDLC.

• Enforce Covance standard testing methodologies, procedures, and practices as they relate to systems validation.

• Participate in resource related activities associated with the team, including demand management, on-boarding and training of staff and partner vendor resources.

• Participate in process related activities associated with the team, test planning, script development, test execution (e.g., Reporting, Metrics), success criteria and measurement, and SOPs to reflect change in roles and responsibilities.

• Learn and use a common set of tools for conducting computer testing, and manage the use of tools associated with testing activities, including HP ALM / Quality Center (Testing Tool).

• Recommend proper testing controls for the BU computer systems to ensure the reliability of applications, as well as the integrity of data and safety of subjects.

• Assure that IT applications components possess the necessary level of testing, and required documentation to comply with applicable GXP regulations and customer requirements/expectations.

• Execute technology, standards, and processes in accordance with department objectives and goals.

• Prepare test models for testing initiatives, and present to project teams.

• Participate with the IT Compliance Audit function in the execution of the continuous improvement model of the Company’s testing methodology and SDLC.

• Partner with Corporate, business unit QA, and IT Compliance Audit functions to assess and leverage supplier information for testing activities.

Education/Qualifications: • 2+ years’ experience in a FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)

• Practical understanding of 21 CFR Part 11 (Electronic Records, Electronic Signatures) as it applies to software validation

Experience: • 2+ years execution of testing projects

• Familiar with various validation methodologies (SDLC), and their implementation in an IT organization

• Working within and maintaining risk based testing methodologies

• IT business process knowledge

• Customer relationship management

• Good verbal, written, and interpersonal skills

• 1+ years working in large IT validation projects

• Proven ability to work in a matrixed environment.

• Ability to plan, organize, and execute work across multiple initiatives to drive delivery of testing commitments

• Ability to interact with peers, BU customers, and mid-level management within the organization

• Ability to manage multiple priorities

• Ability to mentor others team members

• Creative approach to resolving technical issues, and balancing business needs with testing requirements

• Demonstrates self-motivation

• Team player

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.