Job Posting

• Document Management including:
• Editing SOPs, forms, etc.
• Preparing and routing documents for review and approval
• Updating SOP/Form manuals
• Document Repository including:
• Filing documents & Record archiving
• Training Management including:
• Preparing and distributing training records
• Maintaining training records
•  Scanning/copying documents
• Batch record review and product release
• Generate and sign a certificate of compliance for released batches
• Serve as a liaison between the client and its customers
• Scan batch records for record retention
• Retain Management
• Participate in internal audits
• Perform other duties as assigned

Education Requirements:

High School Diploma or GED Equivalent

Experience Requirements:

Must have completed or be able to complete, and understand basic cGMP overview training and basic safety training. Experience in quality assurance in a regulated environment (e.g., FDA, ISO, etc.). 2 years GMP experience preferred.

Beneficial Skills and Training:

• Strong written and verbal communication skills
• Ability to effectively interact with other associates, customers, suppliers, and regulatory authorities
• Results oriented
• Organization and management of multiple priorities
• Proficiency with Microsoft® Office Products
• Accuracy of work and attention to detail
• Ability to work independent of supervision
• Problem solving