Aditi Consulting · 21 hours ago
Specialist Quality Assurance
Holly Springs, NC
Contract
Onsite
Mid Level
$31/hr - $33/hrAditi Consulting is seeking a Specialist Quality Assurance professional to provide quality support and oversight for commissioning and qualification activities. The role involves collaborating cross-functionally to ensure project timelines are met while maintaining compliance with regulatory standards and Good Manufacturing Practices.
AppsConsultingInformation TechnologySoftware Engineering
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
Work with the established QAV team to support the site in the QA Oversite of CQV at ANC for various capital projects
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 Company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with Company’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
Benefits
Medical, dental, and vision benefits
Health savings accounts with qualified medical plan enrollment
10 paid days off
3 days paid bereavement leave
401(k) plan participation with employer match
Life and disability insurance
Commuter benefits
Dependent care flexible spending account
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Accommodations and reimbursement for work travel
Discretionary performance or recognition bonus
Sick leave
Mobile phone reimbursement provided based on state or local law
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
Founded in 1994
1001-5000 employees
H1B Sponsorship
Aditi Consulting 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 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
bloomberglaw.com
2025-10-16
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