Overview
Quality Assurance Specialist Jobs in Durham, NC at LanceSoft, Inc.
Title: Quality Assurance Specialist
Company: LanceSoft, Inc.
Location: Durham, NC
Title: Quality Assurance Specialist (Document Management)
Duration: 12 months
Location: Durham, NC
Pay Range: $35.00 – $40.00/ Hr on W2
Job Description:
• Managing the QA SOPs
• Managing QA training documentation
• Coordinating Auditor schedules for CRO and Internal Inspections
• Archival of QA documentation
• QA metrics
• Creating and distributing the list of outstanding QA audit reports
Responsibilities:
This position will also assist in assuring that planned and systematic processes are established to ensure that the study data are collected, documented, and reported are in compliance and Ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and applicable regulatory requirements (e.g., FDA, ISO).
Initiate External Deviations & Change Control
Create records within eQMS to document external deviations and change controls
This position is required in assuring our company research meets or exceeds all relevant government and company compliance regulations and standards.
Education:
Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Engineering) or equivalent combination of education and experience.
Minimum 1–3 years of experience in a quality assurance/quality operations role within a regulated manufacturing environment.
Working knowledge of GMP, ISO standards, and regulatory requirements for finished goods manufacturing
Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and familiarity with quality management systems (QMS).
Must haves:
Working knowledge of QA R&D or experience in reviewing GLP/GMP/GCP data
Experience working with Veeva nice to have
Must have strong communication, organization and writing skills.
Ability to perform in a multi-task environment.
