Packaging QA Inspector II – GMP & Compliance

Sharp Packaging Solutions, part of UDG Healthcare plc; Macungie (Lehigh County); On-site; USD 38,000 - 52,000; Full time

Job summary

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking a Packaging Associate II (1st Shift) to ensure compliance with work instructions and company requirements during production in specified rooms. The role involves inspections, verification of components, and adherence to batch records to support quality and regulatory standards.

Responsibilities include GMP enforcement, documentation review, and participation in pre/post production checks, with emphasis on accurate data capture and

Qualifications

• High school diploma or GED required; some college preferred.
• Knowledge of FDA regulations related to cGMP is a plus.
• Strong documentation and communication skills are required.
• Experience in manufacturing or similar assembly processes is preferred.

Responsibilities

• Adherence to GMP and quality inspections related to contract packaging and documentation review.
• Read and understand packaging records to ensure compliance during packaging.
• Inspect units for quality at packaging and during inspections per AQL requirements.
• Ensure all packaging requirements are supported by batch records and associated documentation.

Skills

Attention to detail

Documentation

Communication

Organizational skills

Education

High School Diploma or GED

Some college education

Job description

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking a Packaging Associate II (1st Shift) to ensure compliance with work instructions and company requirements during production in specified rooms. The role involves inspections, verification of components, and adherence to batch records to support quality and regulatory standards.

Responsibilities include GMP enforcement, documentation review, and participation in pre/post production checks, with emphasis on accurate data capture and