Quality Assurance - LIMS Analyst

This role will be the Quality organization's Subject Matter Expert (SME) as it relates to the LIMS configuration, implementation, analysis as well as the maintenance in FDBT facilities.

External US

Essential Functions

• Member of a team responsible for coordinating and executing all activities necessary to maintain compliance with cGMP and/or ISO 13485 and the integrity of the Quality Management System.
• Provide troubleshooting expertise to end users on an ad hoc basis, consulting with the software vendor(s) as needed. Work with the vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.
• Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation (CSV) procedures and requirements.
• Develop or review protocol, plans, scripts, reports, SOPs etc. associated with the implementation and maintenance of LIMS systems.
• Serve as the QA contributor on projects including inquiries pertaining to the interpretation of the FDA and other regulatory requirements for computer system validation.
• Execute document and change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
• Participate in cross-functional teams comprised of laboratory, materials management, EH&S, and Quality personnel across multiple sites to expand and improve the use of the LIMS system and to design and implement added-value applications within the LIMS and other local or global lab informatics environments.
• Implement the LIMS workflows and reports to meet business needs.

Required Skills & Abilities

• Self-motivated with a drive for excellence.
• Strong interpersonal skills to include a positive attitude, honesty, integrity, respect, and communication.
• Creative and can work with minimal supervision following internal procedures balanced with independent thinking.
• Resilient through operational and organizational change.
• Exceptional planning and organizational skills and the ability to multi-task and meet deadlines is required.
• Interacts with all departmental staff, including giving training and / or presentations to small and large groups.
• Strong technical aptitude for problem solving and data driven decision making.
• Knowledge of MS Office (Word, Excel, Outlook)
• Ability to write queries with SQL.

Qualifications

• Bachelor's Degree in Biology, Chemistry, Engineering, Information Technology or related discipline and two (2) years' relevant experience in the pharmaceutical/biotechnology industries.
• Administration experience with LIMS and basic programming skills with Python, Java, and other programming languages is required.

Join us!  FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

 

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.

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.