Packaging Associate II - 2nd Shift

Sharp Services • Macungie, PA

95d

About The Position

Function as lead associate responsible for verifying that all systems and processes are compliant with Work Instructions and Company requirements in order to begin and/or finish production activities within a specified room or rooms. Throughout production conduct attribute inspections, asset verifications and component delivery and removals according to the requirements outlined in the associated Batch Record or MPR.

Requirements

• 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 attuned and focused 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.

Nice To Haves

• Knowledge of FDA regulations related to cGMP.
• Prior experience within a manufacturing or alike assembly process.
• General knowledge of quality control processes.

Responsibilities

• Adherence to and enforcement of GMP compliance, performing Quality inspections related to contract packaging.
• Reviewing documentation and verifying component attributes.
• Reading and understanding process steps within the packaging record to ensure compliance during the packaging process.
• Assisting with the overall efficiency of the production within the assigned room or rooms.
• Inspecting units for quality as they are packaged.
• Performing quality inspections as required per the packaging record and per AQL requirements.
• Verifying the accuracy, completeness and supported documentation of the packaging requirements.
• Conducting pre-start equipment room checks and area clearance pages.
• Completing pre-post production pages and pre-packaging steps.
• Performing equipment verification and component startup verification.
• Conducting in-process inspections and quality samples reconciliation.
• Maintaining check weigher sheets and product/component transactions.
• Logging waste and TOR logs as applicable.

Benefits

• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Mandatory overtime may be required if scheduling requires.

What This Job Offers

• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees