Quality Packaging Lead - GMP & Inspections

Sharp Services; Allentown (Lehigh County); On-site; USD 38,000 - 47,000; Full time

Benefits offered by this job

Competitive salary and benefits

Opportunities for continuous learning

Job summary

Sharp is seeking a Packaging Associate II to verify compliance with work instructions and company requirements within packaging areas. You will conduct inspections, verify documentation, and support production steps to ensure quality and regulatory compliance.

Responsibilities include reading batch records, performing pre-start checks, and ensuring accurate packaging records and material traceability throughout the production process.

Qualifications

• Knowledge of GMP standards and regulatory requirements.
• Ability to read and interpret packaging batch records and related documentation.
• Detail-oriented with strong documentation accuracy and traceability.

Responsibilities

• Adhere to GMP and company quality requirements during packaging operations.
• Perform equipment and component inspections and ensure results align with batch records and MPR.
• Read and understand packaging steps to ensure compliant execution.
• Assist with overall production efficiency within the assigned room(s).
• Inspect units for quality as they are packaged and recorded.
• Conduct quality inspections per packaging records and AQL requirements (visual, functional, destructive, counting).
• Verify documentation completeness and accuracy of packaging requirements.
• Perform pre-start checks, area clearance, pre/post production pages, and equipment startup verifications.

Skills

GMP compliance

Quality inspections

Batch records

Process steps

Job description

Sharp is seeking a Packaging Associate II to verify compliance with work instructions and company requirements within packaging areas. You will conduct inspections, verify documentation, and support production steps to ensure quality and regulatory compliance.

Responsibilities include reading batch records, performing pre-start checks, and ensuring accurate packaging records and material traceability throughout the production process.