Quality Systems Associate Senior

Posted 10 Sep 2020

Sheboygan Falls, Wisconsin - United States

Req Id 210094

Details

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 performance materials. 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:

 

  • 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

RSRMS

 

RSRMS

 

 

 


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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