Manufacturing Associate

Shift Schedule: Standard shift begins at 7:30AM for a daily meeting, and will end at 4PM, Monday through Friday.

Job Description:

The Manufacturing Associate I, Endotoxin, is responsible for supporting upstream and/or downstream aseptic manufacturing activities for Limulus Amebocyte Lysate (LAL) products in an ISO 5 cleanroom environment. The role involves setting up and operating production equipment in the LAL Filling and Finishing areas in accordance with established company procedures, departmental SOPs, and current Good Manufacturing Practices (cGMPs). Responsibilities include aseptic processing, product inspection, component kitting, and final packaging of finished goods. The position contributes to product quality, operational efficiency, personnel safety, and compliance with applicable regulatory and site requirements.

Key Accountabilities

1. Execute Manufacturing Operations: Perform aseptic manufacturing, filling, finishing, inspection, and packaging activities in accordance with approved SOPs, production schedules, and cGMP requirements.
2. Maintain Aseptic Processing Standards: Complete cleanroom gowning, aseptic processing, equipment setup, equipment operation, and environmental monitoring activities while minimizing operator-related personnel excursions and environmental monitoring (EM) events.
3. Ensure GMP Documentation Compliance: Accurately complete production records, SAP transactions, and other required documentation in accordance with Good Documentation Practices (GDP) and established procedures, minimizing documentation errors.
4. Perform Product Inspection and Packaging: Complete product sample submissions, inspection proficiency testing, product inspections, component kitting, and final kit packaging according to approved quality standards.
5. Operate and Maintain Production Equipment: Set up, operate, and use cleanroom and finishing equipment safely and effectively, following approved operating procedures and completing required equipment-related documentation.
6. Maintain Training and Qualification Compliance: Complete required LAL Cleanroom General Training and LAL Finishing General Training, maintain training compliance, and achieve applicable annual training targets.
7. Promote Safety and Workplace Standards: Participate in safety discussions, safety and Environmental Performance Standards (EPS) observations, and 6S activities while complying with all site safety policies and applicable regulations.
8. Support Quality and Regulatory Compliance: Identify and promptly report deviations, product defects, documentation errors, potential GMP deficiencies, and other quality concerns to the appropriate personnel.
9. Contribute to Continuous Improvement: Participate in continuous improvement projects, support efficient manufacturing processes, understand basic LAL process flow, and contribute to achieving annual personnel utilization targets.
10. Support Team Performance and Operational Excellence: Perform assigned duties with minimal operator-related process deviations, work effectively with cross-functional teams, and complete additional responsibilities as assigned.

Required Training and Qualification Areas

A. LAL Cleanroom General Training

• Aseptic processing and gowning.
• Cleanroom equipment setup and operation.
• Environmental monitoring.
• SAP transaction qualification: COR3, COR6, MIGO, and LS26.

B. LAL Finishing General Training

• Finishing equipment setup and operation.
• SAP transaction qualification: COR2, COR6, MIGO, MB1A, LB01, and LS26.

C. Additional Required Training and Proficiency

• GMP and GDP documentation practices.
• Product sample submission.
• Inspection proficiency testing.
• Product inspection process.
• Component kitting process.
• Continuous improvement activities.