ApTask · 3 months ago
Senior Specialist Quality Assurance - Level III (Senior)
Durham, NC
Full-time
Onsite
Mid, Senior Level
$54/hr - $55/hr
2+ years expApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. They are seeking a Senior Specialist in Quality Assurance to ensure compliance with regulatory expectations for the manufacture and testing of sterile pharmaceutical products. The role involves responsibilities such as batch record review, technical protocol review, and executing quality audits.
Human ResourcesInformation TechnologySmall and Medium BusinessesStaffing Agency
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
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
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
ApTask
ApTask is a staffing and recruiting company offering staffing, project, and workforce solutions.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Taj Haslani
Founder
Recent News
Company data provided by crunchbase