Department: Quality

Reports To: Quality Manager - Label Cage

PRIMARY PURPOSE or JOB SUMMARY

The Label Cage Inspector is responsible for developing, implementing and enforcing programs, policies and procedures to maintain compliance. The Label Cage Inspector shall fully comply with all regulatory / cGMP guidelines and Legacy Pharmaceutical Packaging standards and policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Promote and enforce GMP and SOP compliance in a FDA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance with standards.
• Possess a working knowledge of cGMPs, FDA and DEA regulations and Legacy Pharmaceutical Packaging policies and procedures.
• Perform and properly document incoming material inspections
• Perform and properly document review of inspection records
• Perform and properly document material issuance
• Provide support to and coordinate with other departments to ensure product integrity
• Identify and properly document process abnormalities using Notice of Event and/or Deviation
• Comply with all Legacy Pharmaceutical Packaging standards and policies
• Perform other duties as required.

ACCOUNTABILITY

The Label Cage Inspector shall be held accountable for the compliance, accuracy and timeliness of responsibilities and work assigned.

SUPERVISORY RESPONSIBILITIES

None

• High School diploma or GED certificate required, some college preferred
• Must be able to understand and apply cGMP and Quality System Procedures
• Familiarity with Microsoft Office (Word, Excel, PowerPoint).
• Must be highly focused and detail oriented
• Must function well under indirect supervision
• Strong interpersonal communication and accurate documentation skills
• DEA clearance required including drug testing
• Ability to lift up to 50 lbs.

WORKING CONDITIONS

Office/Warehouse environment.

ADDITIONAL COMMENTS

Experience in a cGMP environment preferred