Genesis10 ยท 3 months ago
Senior Specialist Quality Assurance - Level III (Senior)
Durham, NC
Full-time
Onsite
Mid, Senior Level
$54/hr - $55/hr
2+ years expGenesis10 is a company seeking a Quality Assurance professional with relevant educational background and experience in the Pharmaceutical Industry. The role involves ensuring compliance with regulatory expectations and oversight of sterile manufacturing processes.
Information ServicesInformation Technology
Responsibilities
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products
Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills
Must have very strong relationship building skills
Batch record review/approval
Technical protocol review/approval
Equipment qualification protocol review/approval
Deviation review/approval
Execute shop floor quality audits
Technical protocol review/approval
Execute shop floor quality audits
Qualification
Required
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 2 years experience in the Pharmaceutical Industry
Would consider Associates w/good relevant experience
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer
Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills
Must have very strong relationship building skills
Preferred
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products
Client-X, Manufacturing Execution System would be a plus, familiar with SAP a plus
Company
Genesis10
Information Technology and Services
1001-5000 employees
H1B Sponsorship
Genesis10 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 (126)
2024 (68)
2023 (20)
2022 (2)
2021 (13)
2020 (29)
Funding
Current Stage
Late StageLeadership Team
Harley Lippman
CEO and Founder
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