SPECTRAFORCE · 2 days ago
Quality Assurance Specialist – CSV & Automation
Holly Springs, NC
Contract
Onsite
Mid, Senior Level
$33/hr - $36/hr
3+ years expSPECTRAFOR is a company focused on providing quality assurance in the biopharmaceutical manufacturing sector. The Quality Assurance Specialist will oversee commissioning and qualification processes with a specific emphasis on Computer System Validation and Automation support, collaborating closely with DTI and ensuring compliance with regulatory standards.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Keshav Bharti
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, with an emphasis on Computer Systems Validation (CSV)
Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight
Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution
Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors
Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements
Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation
May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders
Provide quality guidance and 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, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
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
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
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