QC LIMS Technician I

Overview: The QC LIMS Technician I is accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The QC technician will work under the guidance of other experienced LIMS team members for guidance. S/he will be responsible to implement approved configuration changes within the LIMS platform as outlined in controlled change management records. The position will also be accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.
The QC LIMS Technician is responsible for configuration and ongoing maintenance of the Laboratory Information Management System. This positon is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures. The LIMS Technician works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.External US:MAJOR ACTIVITIES AND RESPONSIBILITIES:

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  Work within the change management system to update configurations for specifications, analyses and other static data within the Laboratory Information Management System (LIMS), as needed.
• Provide timely response to user needs to include troubleshooting applications, creating new configuration templates, and maintaining change records in accordance with version control procedures.
• Provide LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, AD and Manufacturing staff
• Develop and maintain reports in System using reporting tools both internal and external to the System.
• Collaborating with the LIMS team, IT department, and LIMS users to ensure new functionality meets user requirements.
• Revision of supporting documentation for LIMS: SOPS, Work Instructions, Design Specifications, training materials
• Support the expansion of the LIMS platform through the preparation and execution of test scripts for system validation.
• Liaison with end-users in the Laboratory to ensure changes to configurations meet the needs of the end user.
• Revise or develop LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation.
• Performs other related duties as assigned.

BACKGROUND REQUIREMENTS:

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  B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline (with hands on laboratory experience preferred)
• At least 1 year of experience with the use of Labware LIMS and/or working with a LIMS in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics)
• Experience with laboratory instrumentation, software and their interfacing
• Thorough knowledge of cGMP/lCH/FDA regulations with 21 CFR Part 11 and GAMP knowledge a plus

Desired Experience

• Experience with change control and software validation preferred
• Excellent oral and written communication skills

Specific Skills and Competencies

• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
• Capable of interfacing with multiple levels of people within the organization, including corporate management, and plant personnel.
• Excellent verbal and written communication skills and attention to detail.
• Understanding of the pharmaceutical/biotech testing cycles or requirements.
• Technical writing and problem solving skills required.
• Ability to work cross-functionally with a diverse team.
• Experience in Trackwise system preferred.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.
FDBU 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.
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.