Quality Packaging Associate II - 1st Shift

Sharp Corporation; Allentown (Lehigh County); On-site; USD 42,000 - 58,000; Full time

Benefits offered by this job

Competitive salary and benefits

Opportunities for continuous learning

Team-focused culture

Job summary

Sharp Packaging Services, a global supplier of pharmaceutical packaging solutions, seeks a lead associate to verify that all systems and processes comply with Work Instructions and batch records in designated production areas. You will perform attribute inspections, asset verifications, and component deliveries as required.

You will enforce GMP, review documentation, and conduct various quality inspections (visual, functional, destructive, and count checks) to ensure regulatory compliance and

Qualifications

• GMP compliance adherence and enforcement.
• Quality inspections across packaging processes and materials.
• Reviewing documentation to verify attributes and batch records.

Responsibilities

• Adhere to GMP and enforce compliance in production areas.
• Perform quality inspections (visual, functional, destructive, count) per packaging records.
• Review and verify component attributes and packaging documentation.
• Ensure accuracy and completeness of Batch Records and related documentation.
• Maintain compliance with pre-start/area clearance pages and equipment verifications.
• Support overall production efficiency within assigned rooms.

Skills

GMP compliance

Quality inspections

Documentation review

Process verification

Job description

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

• 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.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We've built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world's leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.