Senior Quality Assurance Auditor

The Senior Quality Assurance Auditor position will maintain, implement, and improve the established quality system at CDI.  

Skills and responsibilities:

• Review and approve QC data.
• Perform batch review and release.
• Manage the label control system.
• Audit internal facilities and systems.
• Perform material receipt inspections.
• Perform vendor/contractor audits, as needed.
• Audit software validation and equipment qualification protocols, data, and reports.
• Create and revise quality assurance SOPs.
• Review quality system documents.
• Manage document control of protocols, SOPs, work instructions, and forms.
• Coordinate the archival of paper and electronic data.
• Provide group training presentations on an as needed basis.
• Provide GLP QA support, as needed.
• Perform related duties, as assigned.

Qualifications:

• BS in Biology or related field.
• Four years of experience relevant to quality assurance. 
• A clear understanding of and working experience with FDA GMP and GLP regulations.
• Excellent written and oral communication skills.
• Skilled in conflict management.
• Excellent project management abilities.
• Expertise using MS Word.
• Ability to travel.

Apply online