Senior Quality Assurance Specialist

California; Waukegan (IL); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Software Quality Assurance Engineer with extensive experience in the medical and pharmaceutical sectors. This role is pivotal in ensuring the quality and compliance of software deliverables throughout the software development lifecycle. You will leverage your strong validation skills and collaborate with cross-functional teams to meet business needs while adhering to GxP regulations. If you are passionate about quality assurance and have a knack for automated testing, this is an exciting opportunity to make a significant impact in a dynamic environment. Join a team that values excellence and innovation!

Qualifications

• 7+ years of experience in Software Quality Assurance and SDLC validation.
• Strong understanding of GxP regulations and validation principles.

Responsibilities

• Review and approve SDLC deliverables ensuring compliance with regulations.
• Collaborate with development teams to assure quality of deliverables.

Skills

Software Quality Assurance

SDLC Validation

Automated Testing

GxP Regulations

Risk Assessment (FMEA)

Review of CAPA's

Change Control

Tools

Salesforce

Veeva

JIRA

Confluence

Client-ALM

Tosca

Qtest

M-Files

Job description

Job Title: Software Quality Assurance Engineer (Experience in Medical/ Pharma sector is mandatory)

Duration: 24 Months

Location: Multiple Locations, Alameda, CA

Job Duties:

1. Software Quality Assurance with Review and Approval Experience for SDLC Deliverables
2. Experience in SDLC/Software Validation with writing and execution Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release.
3. Several years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification)
4. Support as SQA in the Review and Approval and implementation of regulated IT applications.
5. Collaborate with the development team to build compliance capabilities to assure the quality of the deliverables and ensure business needs are met.

Experience Required:

1. Strong Validation Resource with 7+ years Experience
2. Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
3. Previous experience with automated testing and implementation.
4. Proficient in understanding GxP regulations and validation principles
5. Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation
6. Prior experience with Salesforce and/or Veeva.
7. Familiarity with a range of applications/tools including JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, or other continuous integration tools.
8. Knows the difference between Waterfall and Agile software development methodologies.

Seniority Level:

Mid-Senior Level

Employment Type:

Contract

Job Function:

Quality Assurance