Aseptic Sterility Assurance Scientist - Night Shift

Medasource; Charlotte (NC); Presencial; USD 76 000 - 90 000; Tempo parcial

Resumo da oferta

Medasource is seeking an experienced Sterility Assurance Scientist to support parenteral manufacturing operations on the Charlotte, NC shop floor. This role requires strong aseptic processing, sterility assurance, environmental monitoring, and contamination control expertise.

The position offers 12-hour night shifts on a rotating 2-2-3 schedule, with initial training conducted on day shift. You will collaborate with Manufacturing, Quality Assurance, EM, and technical teams to maintain cGMP

Qualificações

• Bachelor's degree in a life-science or related field.
• Experience in a cGMP pharmaceutical environment.
• Hands-on troubleshooting on manufacturing floor.
• Experience with deviation investigations and CAPA development.
• Ability to train and mentor manufacturing staff.
• Able to work 12-hour night shifts on a rotating schedule.

Responsabilidades

• Provide hands-on technical support to manufacturing personnel during aseptic production activities.
• Monitor aseptic practices and reinforce cleanroom procedures.
• Troubleshoot process issues and respond to events requiring aseptic interventions.
• Support remediation activities, including recovery cleaning and CAPA implementation.
• Coach operators on aseptic techniques, gowning, and contamination control.
• Collaborate with QA, Operations, and technical teams to ensure sterility and product quality.
• Lead deviation investigations and root cause analysis, and develop CAPAs.
• Analyze manufacturing, microbiology, and EM data to identify trends and opportunities for improvement.
• Support qualification, validation, and contamination control strategy implementation.

Conhecimentos

Aseptic processing

Environmental monitoring

Sterility assurance

cGMP

Root cause analysis

CAPA

Manufacturing floor experience

Training/mentoring

Formação académica

Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Ferramentas

Veeva Vault Quality

TrackWise

Kneat

PharmaSuite

PI Vision

Descrição da oferta de emprego

Medasource is seeking an experienced Sterility Assurance Scientist to support parenteral manufacturing operations on the Charlotte, NC shop floor. This role requires strong aseptic processing, sterility assurance, environmental monitoring, and contamination control expertise.

The position offers 12-hour night shifts on a rotating 2-2-3 schedule, with initial training conducted on day shift. You will collaborate with Manufacturing, Quality Assurance, EM, and technical teams to maintain cGMP