Tap Growth ai · 2 hours ago
Quality Assurance Associate
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
5+ years expTap Growth ai is seeking a detail-oriented and dedicated Quality Assurance Associate to ensure the highest quality standards in their products and services. The role involves supporting the review of batch documentation and the release of internal and external commercial products while ensuring compliance with regulatory requirements.
Research
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
Additional job responsibilities may be assigned
Qualification
Required
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
Strong organization, administrative and data entry skills
Preferred
Experience using Veeva and/or GLIMS
Company
Tap Growth ai
Premium solution for fast growing companies.
Founded in 2022
51-200 employeesFunding
Current Stage
Growth StageCompany data provided by crunchbase