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Title: Manufacturing Documentation Specialist
Hiring Organization: Connexion Systems & Engineering

• Duration: Temp to Perm
• Pay rate: $27-30/hr
• Job Location: Bedford, MA
• Job# 15367

Overview

• Understands and adhere to requirements related to Cleanroom standards, cleanroom mfg process documents.
• Attention to detail related to written specifications and manufacturing instructions to assemble a variety of medical devices
• Evaluate product assembly to company quality standards 
• Work closely with other employees and supporting departments to address nonconformities relate to documentations within the Manufacturing Instructions of the product.
• Perform cGDP (Current Good Documentation Practice) review of completed Manufacturing Instructions
• Release Production Manufacturing Instructions to the production floor in the Inventory Management database
• Perform receipt transactions of completed Manufacturing Instructions
• Perform closure of lots in the Inventory Management database
• Perform closure of Time and Labor closure of completed lots
• Responsible for resolving GDP issues with Document Control and the Quality Departments when required
• Responsible for training Direct Labor on adherence to cGDP and GMPs (Good Manufacturing Processes).

• High school diploma or equivalent required
• Ability to read and interpret standard operating procedures and manufacturing instructions
• Ability to document assembly processes and procedures.
• Prior Medical device assembly experience or working with small parts is a plus
• Candidate should have good eyesight, hand dexterity (hand coordination) and attention to detail
• Able to sit/gown for extended periods during the shift
• Able to work in an environment with low and occasionally increase background  noise
• Experience with a quality background is required
• Experience with Med Device inventory management and transactions is a plus
• Prior experience using software to process transactions required. Experience processing transactions through Great plains preferred

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