Quality Control Equipment & Software Administrator

Posted 13 Jun 2022

St. Louis, Missouri - United States

Req Id 250374

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 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.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


Your Role:

MilliporeSigma, the QC Equipment & Software Administrator is within the Quality Control department and is responsible for introducing, maintaining, and administrating analytical equipment & software per 21CFR Part 11 & EU Annex 11 guidelines and regulations including appropriate data integrity.  This role will be reporting onsite to one of our St. Louis facilities. 

  • Source, purchase, introduce, and maintain required analytical equipment necessary to support analytical testing
  • Manage the change control process as related to equipment management and performing the technical review of IOQ documentation for introduction and maintenance of analytical equipment including requalification activities
  • Support instrument qualifications by authoring URS documents as well as executing internal qualification processes
  • Act as a software administrator for all QC analytical equipment, including management of user accounts and roles
  • Investigate deviations or assist in the investigation of deviations as needed
  • Ensure proper instrument performance, the individual will perform monthly preventive maintenance or work with vendors to schedule appropriate maintenance
  • Ensure data integrity by performing Data Integrity and Audit Trail Risk Assessments on all new and upgraded computerized systems.  Data integrity may also require drafting and reviewing equipment procedures and protocols and performing regularly scheduled data integrity checks

 

Physical Attributes

  • Push/pull/lift up to 40lbs  

 

Who You Are:

 

Minimum Qualifications:

  • Bachelor’s Degree in a Life Science field
  • 5+ years of laboratory GMP experience in pharmaceutical, biopharmaceutical

 

Preferred Qualifications:

  • Master’s Degree in a Life Science field
  • Broad range of experience performing and/or troubleshooting analytical equipment to support bio-organics, protein, or bio-conjugate products.  These techniques may include UV, chromatography (LC, GC, IC), capillary electrophotography, Total Organic Carbon testing, Atomic Absorption, FTIR, Karl Fischer Testing, and wet chemistry techniques
  • Working knowledge of multiple analytical instruments, particularly chromatography systems
  • Chromeleon experience
  • Working knowledge of laboratory management systems, LabVantage LIMS and/or TrackWise 
  • Prior Instrumentation qualification experience include UV, HPLC, LC-MS, GC, TOC, AA, pH meters, turbidimeters, CGE, iCE, particle size analyzer etc. ​​

 


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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