Sharp Services · 3 days ago

Packaging Associate II

Allentown, PA

Full-time

Onsite

Senior Level

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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 production within assigned rooms.

Inspecting units for quality as they are packaged.

Performing quality inspections as required per the packaging record and AQL requirements.

Verifying accuracy, completeness, and supported documentation of packaging requirements outlined in the Batch Record.

Completing various checklists and logs related to equipment, components, transactions, and waste.

Daily contact with Quality and Operations departments related to Quality and cGMP.

Qualification

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FDA regulationsDocumentationQuality@Source trainingReport writingMathematical operationsRecord-keepingProblem-solvingAttention to detailOrganizational skillsCommunication skillsInterpersonal skillsQuality control processesManufacturingAssembly processHard-working

Required

High School Diploma or GED required

Knowledge of FDA regulations related to cGMP is desired

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

Ability to write routine reports and correspondence

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

Ability to apply basic mathematical operations to assigned tasks

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