SSi People · 6 days ago
Quality Assurance Specialist
Holly Springs, NC
Contract
Hybrid
Mid Level
$27/hr - $28/hrSSi People is a company with over 26 years of industry experience, dedicated to putting people first. They are seeking a Quality Assurance Specialist to provide quality support and oversight of commissioning and qualification processes, ensuring compliance with regulations and client requirements.
Human ResourcesInformation TechnologyIT ManagementLinuxProfessional ServicesSoftwareStaffing Agency
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 client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with client'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
Ability to be onsite and gown in, and/or wear construction gear and steel toe boots
Experience in quality support and oversight of commissioning & qualification and process qualification
Ability to collaborate cross-functionally to ensure project timelines and milestones are met
Experience in performing quality review of documents to support facility commissioning and qualification
Knowledge of Commissioning / Qualification Protocols
Experience with Performance Qualification Protocols (PQ)
Ability to review and approve protocol discrepancies
Experience in reviewing Final Reports and Summary Documents
Ability to provide quality support during execution of commissioning and qualification testing
Knowledge of applicable regulations and client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ability to ensure documents comply with client's procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP)
Ability to provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies
Experience in participating in meetings related to document planning, execution, and issue resolution
Ability to escalate any compliance concerns or critical gaps to QA management
Company
SSi People
SSi People, located in Cranberry Township, PA, is an organization with over 25 years of staffing industry experience across various labor verticals in the United States, serving Fortune 1000 companies.
Founded in 1998
51-200 employees
H1B Sponsorship
SSi People 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 (1)
2020 (6)
Funding
Current Stage
Growth StageRecent News
Company data provided by crunchbase