Qc auditor

• Execute Quality AQL inspections of product attributes for manufactured products at Shawnee
• Review of floor documentation and ensure GMP and GDP requirements are followed
• Conduct gowning and line/room audits
• Ensure correct expiration and manufacturing dates / formats are utilized in manufacturing
• Logbook review and approvals for all manufacturing and maintenance areas/processes
• Provide Quality and GMP oversight for all manufacturing and maintenance areas/processes
• Support production operations using good decision-making skills and critical thinking, to ensure compliance is maintained
• Provide clear & effective communications to Quality and Production Management regarding audit findings and/or areas of concern
• Maintains safe environment and follows company safety procedures

• Associate degree or equivalent level of pharmaceutical experience
• Minimum two+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
• Experience in manufacturing and cGMP auditing
• Knowledge of FDA regulations (or similar regulated environment) to include Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
• Basic computer skills are required
• Incumbent must demonstrate strong interpersonal, written, and verbal communication skills
• Manages objectives and balances commitments to prioritize and complete activities within established timelines
• Fluent (written & verbal) in English
• Critical thinking and good decision making is essential to the role

• A scientific background is preferred
• Experience in a quality-related field is preferred

Opportunity for growth