Sr Specialist I QC LIMS

The Sr. Specialist 1 QC LIMS supports the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory corporate and scientific guidelines. The Sr. Specialist 1 QC LIMS configures validates and provides ongoing maintenance within the LIMS platform. This role is expected to complete and review change requests validate configurations provide user support and troubleshoot as needed. This role is responsible for implementing approved configuration changes within the LIMS platform as outlined in controlled change management records. The role supports documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. This role ensures the LIMS system meets the requirements of the LIMS procedures. The Sr. Specialist 1 QC LIMS works closely with Quality Control Analytical Development Manufacturing and Quality Assurance to ensure compliance with GMP requirements

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

• Participates in the rollout of Labware Laboratory Information Management System (LIMS) v.8 go live for the site. This includes migration of static data configuration validation and working with colleagues to ensure successful setup of Labware LIMS v.8.
  Collaborates with business subject matter experts to define and document new or revised LabWare requirements
  Configures basic and advanced LabWare LIMS objects including but not limited to: Specifications Analyses Batch Templates Test list QC samples Calculations Format Calculations and Various Templates (Stability Sample Login Standards and Reagents)
  Executes qualification or verification testing to support final implementation of LabWare configuration additions/revisions
  Maintains and if necessary repairs configuration objects within Labware LIMS
  Supports in creating queries to support business requirements
  Works within the change management system to update configurations for specifications analyses and other static data within LIMS as needed
  Provides timely response and user support including troubleshooting applications creating new configuration templates and maintains change records in accordance with version control procedures
  Provides LIMS training technical support problem reporting and resolution(s) to Quality Control laboratory QA AD and Manufacturing staff as needed
  Evaluates data generated and/or stored within the System to provide ad hoc and longterm reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed
  Writes test scripts for new LIMS functionality and participate in the validation of new functionality releases
  Develops and maintains process configurations in System based on end user procedures and requirements
  Collaborates with the LIMS team IT department and LIMS users to ensure new functionality meets user requirements
  Creates and revises supporting documentation for LIMS: SOPS Work Instructions Design Specifications training materials
  Supports the expansion of the LIMS platform through the preparation and of test scripts for system validation
  Liaises with endusers in the Laboratory to ensure changes to configurations meet the needs of the end user
  Revises or develop LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation
  Performs other related duties as assigned

Basic Requirements

• B.S. degree in Computer Sciences Information Technology Biology Microbiology Biochemistry or other relevant scientific discipline with
  2 years of experience
• 13 years experience working in a cGMP Quality Control department or in a FDA regulated industry /biologics)
• Previous experience with Labware LIMS development or other LIMS software development

Preferred Requirements

• MS degree in Computer Sciences Information Technology Biology Microbiology Biochemistry or other relevant scientific discipline with 0 years experience
• Leadership aptitude is beneficial
• cGMP/ ICH/ FDA regulations with 21 CFR Part 11 and GAMP experience preferred
• Trackwise System experience for at least 1 year or similar

Working Conditions & Physical Requirements

• Ability to sit for prolonged periods of time up to 240 minutes
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs hands and/or fingers.
• Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.
• Ability to conduct work that includes moving objects up to 10 pounds

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin disability protected veteran status sexual orientation gender identify or any other protected class. If an accommodation to the application process is needed please email.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .