Kelly Science, Engineering, Technology & Telecom · 17 hours ago
Senior Technical Writer Contract
Morrisville, NC
Contract
Onsite
Senior Level
$35/hr - $45/hr
5+ years expKelly Science, Engineering, Technology & Telecom is seeking a Senior Quality Assurance Specialist for a contract position. This on-site role is responsible for ensuring compliance with cGMP regulations in a sterile pharmaceutical manufacturing environment by performing document reviews, internal audits, and visual inspections.
Staffing & Recruiting
Hiring Manager
Jenney Tidwell
Responsibilities
Perform quality review and approval of GMP documentation, including batch records, logbooks, forms, protocols, and reports
Issue and control GMP documents to support manufacturing operations in sterile cleanroom environments
Conduct visual inspections of parenteral drug products (qualification required) for defects or particulate contamination
Execute internal audits and support external client and regulatory inspections
Maintain and update quality databases and ensure proper document control
Provide floor support to manufacturing teams and guide adherence to aseptic techniques and cleanroom behavior
Assist in the development and revision of SOPs, forms, and quality procedures to meet regulatory standards and improve processes
Collaborate cross-functionally to support batch review, deviation resolution, CAPAs, training, and vendor qualification efforts
Serve as a mentor or resource for less experienced QA team members
Qualification
Required
Bachelor's degree in Chemistry, Biology, or a related field
Minimum 5+ years of GMP experience in quality assurance, preferably in sterile manufacturing
Familiarity with Annex 1, aseptic processing, and Grade C gowning requirements
Ability to meet visual inspection standards (20/20 corrected vision)
Strong understanding of FDA and international cGMP regulations
Experience working in environments requiring strict contamination control
Preferred
Master's degree
Benefits
Fully Benefited
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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