Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $18.60- $20.60/hr.
Summary:
This position will, under BPO supervision, execute deliverables for a project to implement a 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.
This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which include, but is not limited to, expectations of training and documentation practices.
Responsibilities: Participating 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 provide input on training materials
Support training material development by providing input and reviews
Support site Instrument Qualification activities such as planning and execution
Top Must Have Skill Sets: GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
Experience in development and validation testing of software used in a GMP environment.
Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
Experience in the use of other industry systems such as Veeva & Empower.
Experience in testing or with processes involving analytical methods.
Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).
Excellent problem-solving capabilities and attention to detail.
Experience of collaboration within and across functional areas.
Excellent written and verbal communication skills.
Pay Transparency: The typical base pay for this role across the U.S. is: $18.60 – $20.60/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant’s personal information as well as applicants’ rights over their personal information, please see our Privacy Policy ((url removed)).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting