Ubertal Inc. · 17 hours ago
Senior Quality Assurance Associate
Holly Springs, NC
Contract
Onsite
Senior Level
$38/hr - $44/hr
5+ years expUbertal Inc. is seeking a Senior Quality Assurance Associate to support batch documentation review and batch release activities for commercial products. This role ensures compliance with cGMPs and regulatory requirements while prioritizing record review and release decisions to meet business needs.
Information TechnologyStaffing Agency
Responsibilities
Certify and/or reject incoming and manufactured materials in compliance with applicable licenses, legal, and regulatory requirements
Ensure adherence to regulatory requirements, internal and external guidelines, SOPs, and specifications related to batch record review and product release
Identify, document, and escalate non-compliances impacting batch release for timely resolution
Create and maintain QA SAP Master Data in support of batch release activities
Populate and approve Lot Release Protocols (LRPs)
Support LRP revisions and GLIMS data builds
Support development, revision, and implementation of SOPs and supporting documents governing batch release activities
Author, review, and QA-approve SOPs, protocols, reports, and work instructions
Perform additional QA responsibilities as assigned
Qualification
Required
Minimum 5 years of experience in Pharmaceutical Quality
Hands-on experience with SAP, preferably using SAP for batch release activities
Strong organizational, administrative, and data entry skills
Solid understanding of cGMP and regulatory compliance requirements
Preferred
Experience with Veeva and/or GLIMS systems
Company
Ubertal Inc.
We create disruptive solutions so you innovate faster.
201-500 employees
H1B Sponsorship
Ubertal Inc. 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
2020 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase