Job Description

1. PURPOSE AND SCOPE OF POSITION:
This position is responsible for the harmonization, life-cycle management and continuous improvement of all GMP quality system elements within the Laboratory Systems technology platform including but not limited to Labware. In this role, the incumbent will serve as the primary representative for Master Data deployment related activities and cross-functional partnerships and collaborations. This is a highly visible role with Cellular Therapy Global responsibility and cross functional influence that has a high degree of impact on departmental performance, broad quality initiatives, Quality Control, Quality Operations and the Business.

2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
• Must have expert GMP, Quality, and in-depth risk management knowledge.
• Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function.
• Must provide guidance to other employees in the interpretation of Master Data within the system across a majority of the job function and manage development of Master Data initiatives and activities by interdisciplinary teams.
• Most have strong authorship and be able to critically review Master Data lists.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity.

3. DUTIES AND RESPONSIBILITIES
• LIMS Specialist will work within the LIMS system, and independently create, update and maintains high quality Master Data within LIMS, and translate specifications within the LIMS system by utilizing current business processes.
• The LIMS Specialist takes ownership by completing any incoming requests in a timely manner. They will escalate any issues and understand the impact towards other sites when changing / updating existing Master Data.
• In order to maintain high quality data, they collaborate with CTDO QC Laboratory SMEs to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.
• The LIMS Specialist is able to mentor, lead, and train team members. The Specialist collaborates with more than 1 SME from the different S12 function groups to fully understand the Master Data requirements and will review all configurations for accuracy and completeness. The LIMS Specialist is able to lead small projects within the S12 LIMS Team, e.g. Harmonization / standardization of processes.
• Integrates instruments and applications within LIMS, performs user acceptance testing
• Creates, updates, reviews & approves Master Data (release and stability) including worksheet templates, ELN templates and sample plans.
• Management of Master Data. Examples include: – create/ modify tests, products, sample groups templates, specifications, methods, materials, etc
• Special permissions to support site business users (edit of locked data, moving data to non-routine phases, folder creation, etc)
• Work with site admins on complex issues as required Stability-specific specialty expected to support:
• Stability data management: create/modify stability protocol, stability specification, intervals, conditions, locations, etc. ELN-specific specialty expected to support:
• Site-specific ELN templates and master data (yet to be defined) Quality Control experience required.

4. EDUCATION AND EXPERIENCE

Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.

5. WORKING CONDITIONS:
Work is performed in a typical office environment and remotely, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

How to Apply

Job Types: Temporary.

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