Equipment & Software Administrator - Quality Control

Posted 04 Sep 2019

St. Louis, Missouri - United States

Req Id 196790

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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:

The Equipment & Software Administrator position within the Quality Control department is responsible  for introducing, maintainining, and administrating analytical equipment & software per 21CFR Part 11 & EU Annex 11 guidelines and regulations including appropriate data integrity.

  • The Equipment & Software Administrator position within the Quality Control department 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 person is would be required to source, purchase, introduce, and maintain required analytical equipment necessary to support analytical testing; manage the change control process as related to equipment management; and perform the technical review of IOQ documentation for introduction and maintenance of analytical equipment including requalification activities.  Additionally, this individual will act as a software administrator for all QC analytical equipment, including management of user accounts and roles.  The individual will lead technical troubleshooting and process improvements to improve laboratory instrumentation performance.  As part of ensuring proper instrument performance, the individual will perform monthly preventive maintenance or work with vendors to schedule appropriate maintenance.  Finally, the individual will be an integral part of ensuring 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

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

Who You Are:

 

Basic Qualifications:

  • 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 electropherography, Total Organic Carbon testing, Atomic Absorption, and wet chemistry techniques. 

Preferred Qualifications

  • BS/BA or MS degree, life sciences preferred
  • 5+ years of GMP experience in pharmaceutical, biopharmaceutical or similar industry desired
  • Working knowledge of multiple analytical software, particularly chromatography systems.  Chromeleon experience preferred.
  • Working knowledge of laboratory management systems, LabVantage LIMS and/or TrackWise experience preferred.
  • May require occasional lifting and pushing of up to 40 pounds.

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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