Lead Packaging Inspector II - 3rd Shift (Quality)

Sharp Services, LLC; Macungie (Lehigh County); On-site; USD 24,796 - 30,307; Full time

Job summary

Sharp Services, LLC in Macungie is seeking a Packaging Associate II for the 3rd shift to ensure GMP-compliant packaging processes. You will verify components, perform quality inspections, and review batch records to ensure accuracy and documentation integrity.

Responsibilities include reading process steps, inspecting units, supporting production efficiency, and performing in-process inspections and checks such as pre-start checks, equipment verifications, and weight checks.

Qualifications

• High School Diploma or GED required.
• Some college education desired.
• Knowledge of FDA regulations related to cGMP is desired.
• Prior experience within a manufacturing or alike assembly process preferred
• Good documentation and communication skills are required.
• General knowledge of quality control processes is desired
• Highly attune and focus on attention to detail is required
• Good organizational and planning skills are required.
• Successful completion of the Quality@Source (Q@S) training assessment for the Quality In-Process Inspections as assigned to this position.

Responsibilities

• Adherence to GMP; perform quality inspections and verify components according to Batch Records and MPR.
• Quality inspections impact regulatory compliance and customer satisfaction.
• Read and understand packaging steps to ensure compliance during packaging.
• Assist with overall production efficiency in the assigned room(s).
• Inspect units for quality as they are packaged.
• Perform inspections per packaging record and AQL requirements (visual, functional, destructive, count).
• Verify documentation accuracy and support, with Batch Record documentation.
• Pre-start Equipment Room Check and Area clearance pages.
• Pre-Post Production Pages, Pre-Packaging Steps.
• Equipment Verification pages; Startup Verification pages.
• In-Process Inspections; Quality Samples; Reconciliation.
• Check weigher Sheets; Product/Component Transactions; Waste logs; TOR Logs as applicable

Skills

Attention to detail

Documentation skills

Communication skills

Quality control knowledge

Education

High School Diploma or GED

Some college education

Job description

Sharp Services, LLC in Macungie is seeking a Packaging Associate II for the 3rd shift to ensure GMP-compliant packaging processes. You will verify components, perform quality inspections, and review batch records to ensure accuracy and documentation integrity.

Responsibilities include reading process steps, inspecting units, supporting production efficiency, and performing in-process inspections and checks such as pre-start checks, equipment verifications, and weight checks.