Manufacturing Associate - ELISA
Repligen Corporation
 Waltham, MA

Overview

This position is in Repligen's ELISA group. The successful candidate will be responsible for the manufacture of ELISA kits and its components as well as in-process testing. The individual must be able to follow oral and written instructions accurately and complete tasks in a timely manner. Experience working in a GMP/ISO/document-controlled environment would be beneficial. Attention to detail and the ability to work in a team environment are essential. Candidates must be willing and able to learn new manufacturing processes as the company grows.

Responsibilities

  • Plate coating, conjugate production, buffer preparation and kit assembly
  • Dispensing, capping, labeling and packaging of reagents
  • Working with automated systems
  • Ensure all ELISA Manufacturing operations are carried out in accordance with the Repligen ISO 9001 Quality Management System
  • Ability to analyze and interpret data and results
  • Maintain an appropriate level of housekeeping and safety within the ELISA Lab
  • Ensure all manufacturing processes are carried out according to approved batch records and SOPs
  • Complete and review batch records for accuracy in a timely manner

Qualifications

  • Requires an AS/BS or equivalent with 1- 2

    • years of relevant work experience.

  • Experience working within ISO9001 and/or GMP documentation and quality systems
  • Experience in aseptic techniques and working in a laboratory setting
  • Willing to work overtime as required
  • Able to lift 25 lbs
  • Proficient in Microsoft Excel and Word
  • ERP knowledge is preferred but not required
  • Excellent verbal and written communication