Manufacturing Associate IV

Biogen SANDBOXResearch Triangle Park, NC
3d

About The Position

Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system. May coordinate or lead process steps as requested Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks. Actively participates in training activities, managing their individual training plan. Trains other associates as required. Executes validation protocols with minimal supervision/direction of others. LI-POT7 Qualifications We are interested in hearing from candidates with a proven track record of success in the following areas: Targeted biopharmaceutical training (Bio-works or equivalent) and/or related military training also preferred Detailed oriented with excellent Additional Information Due to continued growth and the introduction of new technologies across the site, we are looking to identify candidates at all experience levels to support Manufacturing Operations in a cGMP environment. In this role you will be responsible for performing and documenting daily manufacturing operations in a cGMP environment. This involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Applicants will be highly detailed

Requirements

  • Detailed oriented

Nice To Haves

  • Targeted biopharmaceutical training (Bio-works or equivalent) and/or related military training also preferred

Responsibilities

  • Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system.
  • May coordinate or lead process steps as requested
  • Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures.
  • Revises or creates documents as instructed.
  • Key documentation includes batch records, SLRs, and equipment logbooks.
  • Actively participates in training activities, managing their individual training plan.
  • Trains other associates as required.
  • Executes validation protocols with minimal supervision/direction of others.
  • performing and documenting daily manufacturing operations in a cGMP environment.
  • operation of process equipment
  • execution of validation protocols
  • creating/ revising cGMP documents
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