SPECTRAFORCE · 2 hours ago
Quality Assurance Validation Specialist
Holly Springs, NC
Contract
Onsite
Mid Level
$34/hr - $36/hrSPECTRAFOR is seeking a Quality Assurance Validation Specialist to provide quality support and oversight of commissioning and qualification activities. The role involves collaborating cross-functionally to ensure project timelines are met while ensuring compliance with applicable regulations and organizational requirements.
ConsultingCRMInformation TechnologyLegal
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 our organization requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with our organization’s 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
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
Fully onsite position. Candidate must be able to gown in and/or wear construction gear and steel toe boots
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
Founded in 2004
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE 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 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase