Aditi Consulting · 2 hours ago
Quality Assurance Associate
Holly Springs, NC, United States
Full-time
Onsite
Mid, Senior Level
$38/hr - $43/hr
5+ years expAditi Consulting is a company seeking a Quality Assurance Associate to support the review of batch documentation and the release of commercial products. The role ensures compliance with cGMPs, site SOPs, and regulatory requirements while prioritizing record review and communicating release needs throughout the organization.
AppsConsultingInformation TechnologySoftware Engineering
Responsibilities
Batch Release
Responsible for certification and/or rejection of incoming material and manufactured material in compliance with applicable licenses and legal requirements
Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, and specifications related to record review and product release
Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities
Authors, reviews, and QA approves Standard Operating Procedures (SOP’s), protocols/reports, work instructions, etc
Creates and maintains QA SAP Master Data builds in support of batch release
Data population and approval of Lot Release Protocols. Supports Lot Release Protocol revisions and GLIMS data builds for LRPs
Qualification
Required
Must have familiarity with SAP; strong preference for candidates who have used SAP for batch release in a prior role
5 years' related experience in Pharma Quality
Experience using Veeva and/or GLIMS
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 and 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.
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
Company data provided by crunchbase