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Sharp Services · 4 months ago

Packaging Associate II 2nd Shift

Macungie, PA

Full-time

Onsite

New Grad, Entry Level

Sharp Services is a company focused on ensuring compliance with quality standards in production activities. They are seeking a Packaging Associate II who will function as a lead associate responsible for verifying compliance with work instructions and conducting quality inspections during the packaging process.

Health CareLife Science

Responsibilities

Adherence to and enforcement of GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes

The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction

Read and understand process steps within the packaging record to ensure compliance during the packaging process

Assist where needed with the overall efficiency of the production within the assigned room or rooms

Inspect units for quality as they are packaged

Responsible for performing quality inspections as required per the packaging record and per AQL requirements. Inspections may include visual, functional, destructive and count checks

Verify the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensure all are supported by the appropriate documentation within the Batch Record

Pre-start Equipment Room Check and Area clearance pages

Pre-Post Production Pages

Pre-Packaging Steps

Equipment Verification page(s)

Equipment / Component Startup Verification page(s)

Challenges

In-Process Inspections

Quality Samples

Reconciliation

Check weigher Sheets

Product/Component Transactions Waste logs

TOR Logs as Applicable

Qualification

FDA regulationsCGMP complianceQuality control processesDocumentation skillsMathematical skillsAttention to detailOrganizational skillsCommunication skills

Required

High School Diploma or GED required

Good documentation and communication skills are required

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

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals

Ability to write routine reports and correspondence

Ability to effectively interact with associates at all levels within the organization

The ability to apply basic mathematical operations to assigned tasks is required; this includes an understanding of statistical sampling plans, and the ability to calculate time, percentages and decimals

Basic math skills (addition, subtraction, multiplication and division) are required

The ability to make rational decisions pertaining to quality compliance and operational efficiency is required

The ability to resolve problems effectively and efficiently is required

The ability to provide clear, concise and legible documentation within batch records and forms in conformance with basic Good Documentation Practices is required