Equipment and Software Administrator Quality Control

Posted 14 Dec 2021

St. Louis, Missouri - United States

Req Id 236190

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 


Your Role:

 

At Milliporesigma, the Senior Associate Equipment Quality Scientist 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.

 

  • 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
  • May require occasional lifting and pushing of up to 40 pounds

 

 

Who You Are:

Minimum Qualifications:

 

  • High school diploma or GED 
  • 5+ years of laboratory GMP experience in pharmaceutical, biopharmaceutical or similar industry desired

 

Preferred Qualifications

 

  • Bachelor’s or Master’s Degree in a biological, chemical or life sciences related discipline
  • The ideal candidate has a 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 preferred
  • Working knowledge of laboratory management systems, LabVantage LIMS and/or TrackWise experience preferred
  • Prior Instrumentation qualification experience is preferred

 

 


 

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!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

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

If you are a resident of a 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.

 

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