Packaging Associate II 2nd or 3rd Shift

Sharp Corporation; Macungie (Lehigh County); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Learning and development

Life science industry focus

Job summary

Sharp Packaging Services is seeking a lead associate to verify that systems and processes meet Work Instructions and company requirements. You will conduct quality inspections in production, verify attributes, and ensure documentation supports packaging and batches in the assigned room(s).

Responsibilities include enforcing GMP, reviewing records, and performing various inspections (visual, functional, destructive, counts) per AQL requirements to support compliant packaging operations.

Qualifications

• Experience with GMP and quality inspections.
• Familiarity with batch records and documentation control.

Responsibilities

• Perform GMP compliance inspections and verify components, bulk, and finished goods.
• Read and understand packaging records to ensure packaging compliance.
• Inspect units during packaging for quality and document results.
• Verify documentation for packaging requirements and batch records.

Skills

GMP compliance

Quality inspections

Documentation review

AQL checks

Batch records

Job description

Our work truly matters and our resourcefulness can make all the difference in getting life-saving drugs to the people who need them, when they need them. We’re more efficient and effective when we’re not overly bound to a set way of working. Bring your resourcefulness and agility to continue your career at Sharp. 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.

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.