Pilot Manufacturing Associate
Hello,
My name is Crystal Marte and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Pilot Manufacturing Associate for a prominent client of ours. This position is located in Cambridge MA. Details for the position are as follows:
Job Description:
We seek a motivated, Manufacturing Associate to assist in the pilot manufacturing of reagents to support the development of commercial molecular diagnostics products.
Responsibilities:
Maintain compliance with internal work instructions while performing and documenting various bench work tasks including calculation of molar concentrations for dilutions, batch aliquotation, product labeling
Perform pilot manufacturing builds to ensure resupply of internal and external customers with CTA kits consistent with reported needs and timelines
Manage inventory and ordering of raw materials for pilot manufacturing builds
Maintain compliance with 5S processes in all pilot manufacturing area
Assist in the creation and revision of technical documentation including protocols, work instructions, SOPs, batch records
Maintain compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System
If you are interested in hearing more about the position please respond to this posting with your resume attached.Estimated Salary: $20 to $28 per hour based on qualifications.
My name is Crystal Marte and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Pilot Manufacturing Associate for a prominent client of ours. This position is located in Cambridge MA. Details for the position are as follows:
Job Description:
We seek a motivated, Manufacturing Associate to assist in the pilot manufacturing of reagents to support the development of commercial molecular diagnostics products.
Responsibilities:
Maintain compliance with internal work instructions while performing and documenting various bench work tasks including calculation of molar concentrations for dilutions, batch aliquotation, product labeling
Perform pilot manufacturing builds to ensure resupply of internal and external customers with CTA kits consistent with reported needs and timelines
Manage inventory and ordering of raw materials for pilot manufacturing builds
Maintain compliance with 5S processes in all pilot manufacturing area
Assist in the creation and revision of technical documentation including protocols, work instructions, SOPs, batch records
Maintain compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System
If you are interested in hearing more about the position please respond to this posting with your resume attached.Estimated Salary: $20 to $28 per hour based on qualifications.
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