Sr IT Analyst Quality Systems at LOTTE Biologics

Job Locations US-NY-East Syracuse
ID
2023-3148
Category
Information Technology
Position Type
Regular Full-Time

Overview

Lotte Biologics Company Logo

 

We are LOTTE Biologics! A new company, built on 80 years of tradition!

 

We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

 

We deliver therapies that make a Healthier World!

Responsibilities

To help us meet our mission LOTTE Biologics is in need of a Sr IT Analyst, Quality Systems to provide support for global and site-wide systems used in the LOTTE Biologics Syracuse Labs and Manufacturing areas! Support solutions will be aligned with the Lotte IT Strategy and may entail implementation of a commercial off the shelf (COTS) system, a customized COTS system, or the development of a tailored solution. In addition, where applicable, members of the Syracuse Quality Systems group may also serve as system administrator for supported systems.

  • Responsible for supporting one or more scientific and quality applications (examples: LIMS, Document Management, Training, QMS, Lab Notebooks, Chromatography)
  • Coordinates with site and enterprise teams to provide efficient and responsive 24/7 support for these key applications
  • Owns end-to-end responsibility for key applications, ensuring they are reliable, accessible, secure, and comply with applicable regulatory requirements.
  • Manages any issues/updates/upgrades to systems by working with global support groups, software vendors, and end users
  • Develops and maintains procedures and validation documentation to ensure compliant use of systems
  • Acting subject matter expert for applications for internal and external inquiries, including participation in regulatory agency inspections

Remote Position

No

Bonus

10%

Qualifications

  • BS in related technical field or equivalent applicable experience
  • Experience with LIMS, Empower LDAS, Lab Notebooks a plus
  • Experience with Quality Management, Learning/Training Management, or Document Management systems a plus

 

  • Applicable information technology skills
  • Knowledge and training of supported computer system hardware and software
  • Experience working with high performing system administration team
  • System and business analysis skills
  • Knowledge and understanding of applicable regulatory requirements, including experience working in regulated environment (pharmaceutical, medical, financial). Experience and understanding of data integrity requirements a plus.
  • Audit experience with external regulatory agencies

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities.  If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today! 

 

Company Website

Company Profile

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

 

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

 

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

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