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 ideal. 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, reagent production, buffer preparation and kit assembly
- Dispensing, capping, labeling and packaging of reagents
- Working with automated systems
- Adherance to Repligen's ISO 9001 Quality Management System
- Maintain housekeeping and safety within the ELISA Lab
- Execute manufacturing processes according to approved procedures
- Complete and review batch records for accuracy and in a timely manner
- Entry of in-process data into trending databases
Qualifications
- Requires an AS/BS or equivalent with 0- 2 years of relevant work experience.
- Experience working within ISO9001 and/or GMP documentation and quality systems is preferred but not required
- Experience in aseptic techniques and working in a laboratory setting is preferred but not required
- Willing to work overtime as required
- Able to lift a minimum of 25 lbs
- Proficient in Microsoft Excel and Word
- ERP knowledge is preferred but not required
- QMS knowledge is preffered but not required
- Excellent verbal and written communication