Quality Packaging Associate II - 1st Shift
Sharp Services
Summary
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.
Job description
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
Requirements
- Adherence to and enforcement of GMP compliance
- Performing quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods)
- Reviewing documentation and verifying component attributes
- Read and understand process steps within the packaging record
- Perform quality inspections per AQL requirements including visual, functional, destructive and count checks
- Verify accuracy, completeness and supported documentation of packaging requirements
Benefits
- Competitive salary
- Benefits
- Continuous learning opportunities
Company overview
Sharp Services is a global leader in pharmaceutical contract development and manufacturing services with over 70 years of heritage. The company specializes in three core areas: sterile manufacturing for clinical use and small-scale commercial requirements, comprehensive clinical trial supply services from preclinical to commercial launch, and innovative commercial packaging solutions. With a workforce of over 2,500 employees across state-of-the-art GMP facilities in the United States, United Kingdom, Belgium, and the Netherlands, Sharp provides end-to-end support for pharmaceutical and biotechnology clients. Their expertise spans the entire drug development lifecycle, offering solutions that reduce risk, complexity, and timelines for clinical trials while ensuring regulatory compliance and quality standards. The company's recent $100 million investment in expanding its EU and US facilities demonstrates its commitment to enhancing capabilities and capacity to better serve partners worldwide.