Job Abstract

Position Summary:

The QA Packaging Inspector is responsible for inspecting documentation records, products, facilities and equipment before, during and after packaging runs.

Responsibilities: Responsibilities include, but are not limited to:

• Verification of line cleaning and line release approval on a timely basis
• Monitor packaging/inspection operations for conformance to specifications and procedures
• Sample of packaged product as required for QC Testing, Stability or as required by the packaging record
• Complete packaging logbooks which includes recording of required information neatly and accurately and verification that data entered by operations is neat, complete and accurate
• Perform and verify documentation for packaging qualification
• Maintenance of house standards, comparison of product for physical verification
• Communicate with production personnel which includes but not limited to the availability to perform line cleaning and line release approval, product and/or equipment related quality issues
• Review of packaging documentation
• Inspection of final finished, package prior to end of packaging run and before transfer to warehouse
• Notify QA management of any quality or safety concerns
• Knowledge of cGMPs related to US FDA manufacturing and packaging environments
• Compliance with applicable company policies such as cGMP and related SOPs
• Responsible for compliance with all rules and regulations pertaining to safety policies and for leading by example with the proper attitude toward safety and health help to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.
• Other responsibilities as assigned by Senior management

Education and Experience:

• High School or GED diploma required with college a plus
• Work experience in a quality assurance or GMP environment preferred

Skills, Knowledge and Abilities:

• Knowledge of and ability to perform basic math
• Knowledge of Microsoft Office Programs
• Excellent organizational skills and detail-oriented
• Ability to reach, write and communicate effectively

Physical Demands:

• Required to reach with arms and use hands and fingers to handle or feel objects and tools
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders
• Must be able to lift and/or move up to 50 pounds

Work Environment:

• Work environment in production operations facilities include close proximity to heavy machinery with loud noises and pharmaceutical powders (dust).
• Potential to move between production operations sites/areas to complete job functions.
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• Work location are subject to change as needed to meet business requirements.

Supervisory Responsibilities:

• None

Personal Protective Equipment or Attire Required for Position:

• Gowning as required by GMPs and/or SOPs
• PPE as needed