Jobs · Research · North Carolina

Manufacturing Associate I, Support

Xtalks · Durham, NC · 1 mo ago
ResearchFull-time

About the role

This position is on 2-2-3 shifts, 7a-7p and 7p-7a. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment.

Responsibilities

  • Follow instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms.
  • Ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including 'Right the First Time' (RFT).
  • Maintain a sense of ownership of the production processes, manufacturing environment and facility in activities such as dispensing raw materials, utilizing analytical scales, preparing media/buffers using various equipment like formation tanks/vessels/sumps, assembly preparation, parts washing, and autoclaving.
  • Provide crucial manufacturing support operations requiring a deep understanding of fundamentals and practical skills in the formulation of media/buffers using stainless tanks / vessels / sums including the use of single‑use bags with mixers.
  • Utilize knowledge and prior experience to troubleshoot and continuously enhance daily manufacturing operations in the formulation of media/buffers, leveraging expertise with stainless steel tanks / vessels / sums and the utilization of single‑use bags with mixers.
  • Perform clean‑in‑place (CIP) procedures for tanks and auxiliary equipment, such as transfer pumps, crimpers, tubing welders and sealers, pH/conductivity meters, and filter integrity testers.

Schedule

2‑2‑3 shift pattern: 7 a.m.–7 p.m. and 7 p.m.–7 a.m.

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