Sterility Assurance Scientist - Night Shift (12h)

Eightelevengroup; Concord (NC); Presencial; USD 55.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401k with match

Paid time off

Holiday pay

Employee assistance program

Descripción de la vacante

Medasource in Concord, NC is seeking a Sterility Assurance Scientist for a 12-month contract to support parenteral manufacturing on the night shift. This hands-on role partners with Operations, Quality Assurance, and Environmental Monitoring to maintain aseptic conditions and drive contamination control.

You will mentor staff, lead investigations, perform CAPAs, and contribute to EMPQ, APS, and bioburden strategies while adhering to CGMP.

Formación

• Bachelor's degree in a relevant scientific/technical discipline.
• Experience in parenteral manufacturing and CGMP.
• Hands-on technical support for manufacturing processes.
• Investigation and CAPA development experience.
• Mentoring/training staff in aseptic techniques.

Responsabilidades

• Provide hands-on technical guidance to operators in aseptic processing areas.
• Coach and audit aseptic practices and report events affecting aseptic conditions.
• Troubleshoot process issues and lead remediation activities (recovery cleaning, alarm responses).
• Lead/develop deviation investigations and CAPA effectiveness.
• Gather and analyze environmental and manufacturing data to identify trends and improvements.
• Support EMPQ, APS/media fills, bioburden management, and sterility assurance programs.
• Collaborate with QA, Operations, and TS/MS to assess impact on product quality.
• Mentor scientists and technicians on aseptic requirements and troubleshooting.

Conocimientos

Sterility assurance

Environmental monitoring

Aseptic techniques

Gowning & PPE

CAPA investigations

Cross-functional collaboration

Mentoring/training

Technical troubleshooting

Bioburden control

Educación

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

Herramientas

Veeva Vault Quality

TrackWise

Kneat

PharmaSuite

MODA

PI Vision

Descripción del empleo

Medasource in Concord, NC is seeking a Sterility Assurance Scientist for a 12-month contract to support parenteral manufacturing on the night shift. This hands-on role partners with Operations, Quality Assurance, and Environmental Monitoring to maintain aseptic conditions and drive contamination control.

You will mentor staff, lead investigations, perform CAPAs, and contribute to EMPQ, APS, and bioburden strategies while adhering to CGMP.