Quality Systems Specialist

at MilliporeSigma
Location Sheboygan Falls, Wisconsin
Date Posted June 14, 2021
Category Bioscience
Job Type Full-time
Address 5485 Co Rd V

Description

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

Your Role:

The Quality Systems Specialist at MilliporeSigma will perform duties assigned to support the advancement of Quality Systems and Operations while meeting and exceeding customer requirements and enabling the department to provide the Total Quality Package.

  • Support in establishing the critical process parameters for technology transfers for new and existing products.
  • Design process control communication and data collection standards for master production records.
  • Support the Project Chemists to establish measurable critical process control parameters.
  • Support the Project Chemist in implementation, effectiveness evaluations, adjustments, and communicating change control requirements and instructions.
  • Support the Quality Assurance team in quarterly product reviews for strategic materials.
  • Establish communication and education on critical process parameters to answer the What, Why, Who, and How questions.
  • Create operating procedures and instructions for sustainable process design template.
  • Support Process Engineering in enabling engineering controls, process automation, and enabling and commissioning process analytical technology.
  • Ensure that automation and data technology supports the critical process parameters.
  • Create sustainable data flow of data accessibility and standardization for strategic materials and perform data collecting, contextualizing and modeling.
  • Store contextualized data in purposeful data warehouse available to manufacturing and the business team.
  • Perform fact finding or optimization related batch level multivariate analysis for strategic materials.
  • Work with Automation Engineers and Data Engineers to define elements of predictable manufacturing.
  • Support the customer and product specific task force teams with customer interaction.
  • Collaborate with Chemists and ensure OOC/OOS process standards are defined and contain response flow criteria.
  • Support the Project Chemist in defining the Golden Batch and optimizing the Master production record.
  • Assist in annual product reviews and MRB support functions
  • Participate in customer and supplier audits
  • Perform quality awareness education and refresher sessions.
  • Analyze factual information and possible solutions to make independent judgement, recommendations and decisions while using best practices to improve products or service.

 

Who You Are:

Basic Qualifications

  • Bachelor’s Degree in Chemistry, Chemical Engineering or other Engineering field
  • Course work in chemistry
  • 5+ years in chemical manufacturing.
  • 1+ years in quality control or quality assurance.

 

Preferred Qualifications

  • Master’s Degree or higher level education
  • Experience and/or education in distributed control systems (Siemens Automations preferred), general programing skills, database technologies and data analysis.
  • Excellent mathematical and analytical skills, including knowledge and experience in the application of statistical techniques.
  • Ability to explain complex or difficult/sensitive information to others in straightforward situations and interacts across business areas, in order to advance discussions and build consensus across the business and with external parties regarding own technical area.
  • Ability to perform a range of routine or non-routine assignments to solve problems of low to moderate complexity
  • Ability to work independently, in a fast-paced environment, receiving a low to moderate level of guidance and direction within clear or broad guidelines.
  • Detail oriented, possessing excellent communication and presentation skills.

 

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