Packaging Associate II 2nd or 3rd Shift

Sharp Services, LLC; Macungie (Lehigh County); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Competitive salary

Benefits

Job summary

Sharp Services is seeking a Packaging Associate II to verify GMP compliance and conduct quality inspections in the packaging process, ensuring documentation accuracy and adherence to batch records. The role emphasizes adherence to Work Instructions and company requirements to begin and/or finish production activities within the assigned rooms.

You will read process steps, support production efficiency, perform in-process inspections, and conduct equipment verifications to help deliver safe

Qualifications

• 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.

Responsibilities

• Adherence to GMP compliance, performing Quality inspections related to contract packaging and verifying component attributes.
• Inspect units for quality as they are packaged and perform quality inspections per the packaging record and AQL requirements.
• Verify the accuracy, completeness and supported documentation of the packaging requirements within 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:

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.