Collabera · 10 hours ago
Specialist Quality Assurance
Collabera is seeking a Specialist Quality Assurance to provide quality support and oversight for the commissioning and qualification processes at their facility. The role involves collaborating cross-functionally to ensure project timelines are met and performing quality reviews of documentation related to commissioning and qualification activities.
Responsibilities
Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance
Perform quality review of documents to support facility commissioning and qualification, according to project timelines
Commissioning / Qualification Protocols
Performance Qualification Protocols (PQ)
Review and Approval of protocol discrepancies
Review of Final Reports and Summary Documents
Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required
Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies
Participate in meetings related to document planning, execution, and issue resolution
Escalate any compliance concerns or critical gaps to QA management
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Qualification
Required
Understanding of regulatory requirements, trends, and industry standards
Experience/knowledge in commissioning/qualification/validation, including computer-systems validation
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Great attention to detail and high degree of accuracy in task execution and GMP documentation
Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion
Proven capability and experience applying GMP requirements in an operational and Quality Control setting
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.
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
Recent News
2024-04-09
2023-01-20
2022-04-19
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