Quality Packaging Associate II - 2nd Shift

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

We’re part of a team where ideas spark change. At Sharp we embrace innovation; we are open to new technology and new thinking. Each day we volunteer ideas, ask questions, and encourage others to do the same - always trying to make things better. Our culture celebrates learning and we expand our skills and gain new knowledge with every project and initiative.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to the Packaging Associate II position. Other duties may also be assigned.

• 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 with 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

What We Offer:

• A team that values grit, growth, and good energy.
• Competitive salary and benefits.
• Opportunities for continuous learning and advancement.

We believe it is a privilege to work in the life science industry. We believe that our work matters. We are united through our values and our common purpose which is to help our clients succeed and ensure their patients who have medical needs can live a better life.

Let’s build Sharp. Let’s grow bold. Let’s do more - together.