Quality Management Systems Specialist
2 weeks ago
Company Overview
Lantheus is a leading organization in the medical imaging sector, dedicated to enhancing patient care through innovative diagnostics and therapeutics. With a presence in multiple countries, we pride ourselves on our entrepreneurial spirit and commitment to quality.
Position Summary
We are seeking a dynamic and experienced Business Analyst to join our Quality Systems team. This role is crucial in supporting our Quality business community by executing requirements and collaborating with various technical teams to deliver effective Quality Management System (QMS) solutions.
Key Responsibilities
- Gather, develop, and document functional and user business requirements.
- Translate user needs into clear functional specifications.
- Maintain a strong understanding of Laboratory Information Management Systems (LIMS), with a preference for LabVantage.
- Facilitate the integration of LIMS with Empower CDS.
- Administer at least one QMS solution, such as AsurX, TrackWise, Veeva, or MasterControl.
- Oversee the administration of at least one CDS system, preferably Empower.
- Manage IT setup, troubleshooting, and maintenance of laboratory equipment and software.
Qualifications
- BA/BS degree in Information Technology or Computer Science with a minimum of 5 years of progressive experience in data integration.
- Familiarity with Quality Controls in Manufacturing, Quality Systems & Document Management, and Computer Systems Validation.
- Strong written and verbal communication skills, with an emphasis on collaboration across diverse teams.
- Experience in a GxP validated environment and contributing to validation documentation.
Additional Information
This position may require non-routine overnight travel based on business needs.
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