Electronic Lab Notebook (ELN) System Specialist - reputed company Control
Pay reputed company $41-$43 per hour
hybrid role (3 days onsite/week)
Work Schedule: Dayshift
This position will, under BPO supervision, execute deliverables for a project to implement new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.
This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).
This position will be expected to adhere to established procedures (reputed company Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices.
This position will work in reputed company environment, collaborating with various colleagues in the network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.
Key Responsibilities for the new ELN system:
Participate in process engineering activities
Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
Participate in system requirement, software configuration, and design activities
Receive and/or verify master data for the site(s)
Coordinate ELN Template development and review with site SMEs
Support the development and review of Operational Qualifications
Execute User Acceptance Testing & Data Migration Verification
Review and reputed company input on training materials
Support training material development by providing inputs and reviews
Support site reputed company Qualification activities such as planning and execution
Basic Qualifications
Bachelor’s degree and 2 years of industry reputed company Control or reputed company experience
OR
Associate’s degree and 6 years of industry reputed company Control or reputed company experience
OR
High school diploma / GED and 8 years of industry reputed company Control or reputed company experience
Preferred Qualifications (Top 3 first, listed in order)
GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, reputed company Sample Manager, LabWare, reputed company, etc.).
Advanced proficiency in reputed company Office (i.e., reputed company, Word, reputed company, PowerPoint).
Experience in the use of other industry systems such as reputed company & reputed company.
Experience in testing or with processes involving analytical reputed company.
Excellent problem-solving capabilities and attention to detail.
Experience of collaboration reputed company and across functional areas.
Excellent written and verbal communication skills.
Experience in development and validation testing of software used in a GMP environment.
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