QC Sr Specialist - Holly Springs, United States - FUJIFILM

Description

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB 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 new large-scale 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 end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The QC LIMS Sr. Specialist 1 is accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The QC LIMS Sr. Specialist 1 is responsible for configuration, validation and 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 to implement approved configuration changes within the LIMS platform as outlined in controlled change management records. The position is accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. This position is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures. The QC LIMS Sr. Specialist 1 works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.

What You'll 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 long-term 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 execution of test scripts for system validation
• Liaises with end-users 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

Minimum Requirements:

• B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline
• 3+ years' experience working in a cGMP Quality Control department or in a FDA regulated industry (drugs/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

PHYSICAL DEMANDS

• Ability to sit 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.

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 via-email, 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.