Infotree Global Solutions · 2 days ago
Commissioning & Qualification Specialist
Holly Springs, NC
Contract
Onsite
Mid, Senior Level
3+ years expInfotree Global Solutions is seeking a Commissioning & Qualification Specialist to provide quality support and oversight of commissioning and qualification processes for facilities and systems. The role involves collaborating cross-functionally to ensure compliance with regulatory standards and project timelines while performing quality reviews and providing oversight during testing and documentation processes.
Human ResourcesStaffing AgencyTechnical Support
Hiring Manager
Chandan Sharma
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
Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP)
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
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
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
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
1001-5000 employees
H1B Sponsorship
Infotree Global Solutions 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 (8)
2024 (9)
2023 (11)
2022 (17)
2021 (16)
2020 (19)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Kingswood Capital Management
2025-02-20Private Equity
Leadership Team
Matt Milano
Chief Executive Officer
Klaus Geiser
Chief Financial Officer
Recent News
Company data provided by crunchbase