Description

Job Title: Label Cage Inspector

Department:  Quality

Reports To: Quality Manger Label Cage

Shift: Monday - Thursday 6am - 4pm

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.

1. Promote and enforce GMP and SOP compliance in a FDA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance with standards.

2. Possess a working knowledge of cGMPs, FDA and DEA regulations and Legacy Pharmaceutical Packaging policies and procedures.

3. Perform and properly document incoming material inspections

4. Perform and properly document review of inspection records

5. Perform and properly document material issuance

6. Provide support to and coordinate with other departments to ensure product integrity

7. Identify and properly document process abnormalities using Notice of Event and/or Deviation

8. Comply with all Legacy Pharmaceutical Packaging standards and policies

9. 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

Qualifications

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

• Production areas and/or warehouse environment.
• Up to 25% travel between worksites.
• This position requires the use of your own vehicle to travel between worksites

.ADDITIONAL COMMENTS

Experience in a cGMP environment preferred