Collabera · 20 hours ago
Quality Assurance Analyst
United States
Contract
Remote
Entry, Mid Level
$40/hr - $44/hrCollabera is seeking a Quality Assurance Analyst to support the implementation of Amgen’s electronic lab notebook system. The role focuses on ensuring compliance with quality requirements and involves cross-functional collaboration to deliver project milestones.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Prathmesh Rathod
Responsibilities
Participate in process engineering activities to define and implement new ELN workflows aligned with business and quality requirements
Support system requirements gathering, software configuration, and design activities for the ELN platform
Facilitate the development and revision of SOPs, work instructions, forms, and manuals associated with new ELN processes
Receive, recreate, migrate, and verify master data required for site implementation and production deployment
Coordinate ELN template development and review with site Subject Matter Experts (SMEs)
Support the development, execution, and review of Operational Qualifications (OQ) documentation
Execute User Acceptance Testing (UAT) and data migration verification to ensure system readiness and compliance
Review, provide input on, and support the development of training materials, and assist with instrument qualification planning and execution as needed
Qualification
Required
Experience in implementing electronic lab notebook (ELN) systems
Knowledge of system design, configuration, validation, and deployment in a regulated GxP environment
Understanding of cGMP, CFR, and data integrity requirements
Ability to work cross-functionally with QC, QA, IT, validation teams, and site SMEs
Experience in process engineering activities to define and implement new ELN workflows
Skills in system requirements gathering, software configuration, and design activities for the ELN platform
Experience in developing and revising SOPs, work instructions, forms, and manuals
Ability to receive, recreate, migrate, and verify master data for site implementation
Experience in coordinating ELN template development and review with site SMEs
Skills in developing, executing, and reviewing Operational Qualifications (OQ) documentation
Experience in executing User Acceptance Testing (UAT) and data migration verification
Ability to review and support the development of training materials
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Days/hours of paid sick and safe time
Days/hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
Any additional benefits applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
Founded in 1991
10001+ employees
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2024-04-09
2023-01-20
2022-04-19
Company data provided by crunchbase