Quality Control Associate, Senior LIMS/Stability

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Job Summary

As an AGC Biologics Quality Control Associate, Senior / Scientist I, Stability & LIMS you'll play a vital role in the implementation and administration of LabWare v.8 for various functions including Lot and Location Management, Stability Management, Raw Materials, and Environmental Monitoring. In this dynamic position, you'll create and revise QC sample plans and analytical data within LIMS, ensuring accuracy and compliance with standards. You will respond swiftly to urgent manufacturing and QC LIMS issues, review and approve essential documentation, and provide training to new users, fostering a knowledgeable team environment. Additionally, you’ll assist in drafting technical documents, coordinate stability testing schedules, and maintain a stability calendar. Your proactive approach will support troubleshooting and enhancements in LIMS, while your dedication will ensure smooth operations, even during evenings and weekends. If you’re passionate about leveraging technology to optimize laboratory processes and are eager to contribute to a collaborative team, we want to hear from you!

ESSENTIAL JOB DUTIES

Quality Control Associate, Senior

LIMS

• Assist in the implementation and administration of a Laboratory Information Management System (LIMS LabWare v.8) for Lot Manager, Location Manager, Stability Manager, Raw Materials and Environmental Monitoring
• Create and revise QC Sample plans in LIMS (Labware v7 and v8).
• Create and revise LIMS analytical data in LIMS including, QC tests, specifications, Environmental monitoring sites, Raw Materials, CoAs, and stability protocols (Labware v8).
• Respond to urgent Mfg/QC/QA LIMS issues in a timely fashion.
• Review and revise Standard Operating Procedures and QC Sample records in regards to LIMS functionality.
• Review QC sample plans in the Master Production records or ATT documents.
• Provide training to new LIMS users on functionality.
• Assist with troubleshooting LIMS issues.
• Assist with implementing changes/enhancements in LIMS to address CAPAs and CRs.
• Available to be on call for any urgent LIMS related issues or tasks during evenings/weekends/holidays.

Stability

• Assists with the creation of stability documents.
• Maintains the stability calendar.
• Assists with the scheduling of stability testing.
• Coordinates stability sample pulls and delivery for testing.
• Coordinates data compilation and CoA preparation.
• Assist in drafting technical documents including test methods, validation documents, deviations, and stability reports.
• Assist with the generation of SOPs related to LIMS and stability.
• Perform data verification and data entry in LIMS and CoAs.
• Receives/Ships Stability and other samples for QC testing
• Reviews Vendor test data

Quality Control Scientist I

LIMS

• Assist in the implementation and administration of a Laboratory Information Management System (LIMS LabWare v.8) for Lot Manager, Location Manager, Stability Manager, Raw Materials and Environmental Monitoring
• Create, revise, and approve QC Sample plans in LIMS (Labware v7 and v8).
• Create, revise, and approve LIMS analytical data in LIMS including, QC tests, specifications, Environmental monitoring sites, Raw Materials, CoAs, and stability protocols (Labware v8).
• Respond to urgent Mfg/QC/QA LIMS issues in a timely fashion.
• Review and revise Standard Operating Procedures and QC Sample records in regards to LIMS functionality.
• Review and approve QC sample plans in the Master Production records or ATT documents.
• Provide training to new LIMS users on functionality.
• Assist with troubleshooting LIMS issues.
• Assist with implementing changes/enhancements in LIMS to address CAPAs and CRs.
• Available to be on call for any urgent LIMS related issues or tasks during evenings/weekends/holidays.

Stability

• Assists with the creation of stability documents.
• Maintains the stability calendar.
• Assists with the scheduling of stability testing.
• Coordinates stability sample pulls and delivery for testing.
• Coordinates data compilation and CoA preparation.
• Assist in drafting technical documents including test methods, validation documents, deviations, and stability reports.
• Assist with the generation of SOPs related to LIMS and stability.
• Perform and ap