Quality Assurance Technician II-Quality Systems​/Document Control

Basic Purpose

Issuance of a range of cGMP documentation to support daily processes facility wide.

• Assign numbers per Good Documentation Practices in master logs for GMP document issuances.
• Issuance of Master Records, Notebooks, Logbooks, cGMP forms, etc.
• Ability to compile and enter data in support of Annual Product Quality Reviews (APQRs).
• Ability to review executed documents for adherence to good documentation practices and outlined procedures.
• Navigate and maintain documents in the electronic Quality Management System, Veeva Vault.
• Maintenance of the filing system for the retrieval and archiving of GMP documentation.
• Other duties as assigned by manager

The following describes the general knowledge, skills, qualifications and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.

• High School Diploma
• 5 + years pharmaceutical experience in Document Control Environment (preferred), will consider comparable experience in related field

• Excellent communication skills (written and oral)
• Computer skills
• Good organizational skills
• Work well under pressure
• Strong knowledge of cGMP and FDA requirements
• Working knowledge of pharmaceutical processing, quality assurance/control processes and practices

• Training System Software
• Enforcement Solutions
• Microsoft Office
• Microsoft Outlook

• Ability to lift 25 lbs
• No PPE required unless entered manufacturing or lab areas