Senior Specialist, QC LIMS

Posted 2 Days Ago
Be an Early Applicant
St. Albans, VT
Mid level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Specialist QC LIMS role involves managing LIMS configurations, documentation, troubleshooting issues, and training users while ensuring compliance with regulations.
Summary Generated by Built In

Mylan Technologies, Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via: 

  • Access – Providing high quality trusted medicines regardless of geography or circumstance;

  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 

  • Partnership – Leveraging our collective expertise to connect people to products and services. 

Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist QC LIMS role will make an impact:

Key responsibilities for this role include:

  • Perform tasks associated with the configuration, and maintenance of the Laboratory Information Management System (LIMS).

  • Formally document, evaluate and coordinate modifications to LIMS Master Data in Trackwise® Change Management System (CMS).

  • Contribute to site and corporate projects and initiatives for LIMS and /or Empower. Manage site activities for projects as assigned.

  • Maintain and update documentation for LIMS and Empower related activities (SOP, WI, trainings, etc.) as directed.

  • Analyze and troubleshoot customer issues to help solve technical problems.

  • Interact with local and global support teams, as needed, to resolve technical situations.

  •  Provide guidance and training to end users as needed.

  • Assess the impact to LIMS of changes made to documentation, etc., by other site groups.

  • Assist with routine administrative functions in Empower such as project lifecycle management.

The minimum qualifications for this role are:

  • Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.

  • Must possess knowledge of LIMS systems and master data concepts. Must possess knowledge of Empower chromatography data software or equivalent and regulatory requirements (FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, JP). Must be able to understand and adhere to government regulation, company and departmental policies and procedures. Laboratory and/or pharmaceutical process experience preferred.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Top Skills

Empower Chromatography Data Software
Laboratory Information Management System (Lims)
Trackwise®
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The Company
HQ: Canonsburg, PA
16,557 Employees
On-site Workplace

What We Do

Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.

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