Quality Systems Associate Senior
Millipore Corporation

Job Info

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Your Role:

• Create critical parameter definition and communication standards for Process Monitoring and Control
• Ensure Critical Process parameters are identified and well communicated in Master Production Records. The parameters will be defined by R&D, tech transfers or well established MPR's based on historical data
• Support in establishing customer and product specific analytical requirements
• Assist in setting Statistical Quality Control (SQC) parameters and provide data collection support
• Assist in product specification development and implementation of analytical critical parameters
• Assist in coordinating product hazard evaluation and stability studies
• Coordinate training and communication of Statistical Quality Control (SQC) in manufacturing
• Data assembly for raw materials, manufacturing process and analytical results
• Standardize data collection for strategic compounds
• Create sustainable collecting methods Assemble data and present in a manner that would support: every batch review for commercial products; MRB reviews; improvement initiatives; customer data requests; product development
• Provide marketing, business, product management, operations teams with data upon request
• Support the corporate strategic customer base quality standards
• Coordinate training and compliance with ISO and other company established quality standards
• Review and implement customer and material based change control parameters in manufacturing
• Support creation of operating procedures and master production records
• Monthly performance check reviews
• Support the general and product specific change management functions
• Maintain and support the communication of the customer/product specific quality requirements
• Support the customer and product specific task force teams with some customer interaction
• Support the quality assurance and project management team on Statistical Process Control (SPC) criteria for the strategic designated products
• Establish the critical and process control parameters as part of the technology transfer package
• Implement the critical and measurable process control parameters in master production records
• Batch review of statistical process profile for the strategic products
• Support the quality assurance team in quarterly product reviews
• Coordinate training and communication of the Statistical Process Control (SPC)
• Support in establishing customer and product specific analytical requirements
• Assist in setting Statistical Quality Control (SQC) parameters and provide data collection support
• Assist in product specification development and implementation of analytical critical parameters
• Assist in coordinating product hazard evaluation and stability studies
• Coordinate training and communication of Statistical Quality Control (SQC) in manufacturing
• Perform other duties as assigned to support the advancement of quality systems and operations and meet the quality expectations of our Hitech® materials customer base
• Assist in annual product reviews
• Assist in EMRB support functions
• Participating in customer and supplier audits
• Reviewing manufacturing batch records, as needed
• Support the Total Quality Product Review Strategic products and customers
• Facilitate quality awareness training for the manufacturing operations. Prepare training reports
• Support or lead Quality Improvement and Continuous Process Optimization efforts in manufacturing

Who you are:

Basic Qualifications:

• BS/BA Degree in Science, Engineering or Business/Mathematics, Chemistry or related science discipline
• 1+ year of experience in Quality or Chemical Manufacturing

Preferred Qualifications:

• Excellent oral and written communication skills
• Good Manufacturing Practices and familiarity with ISO Quality Systems
• Detail oriented with strong problem-solving skills

Job Requisition ID: 210094

Location: Sheboygan Falls

Career Level: C - Professional (1-3 years)

Working time model: full-time

This job has expired.