Job Description

Pay Range $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 (Standard 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 a team 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 provide input on training materials

Support training material development by providing inputs and reviews

Support site Instrument Qualification activities such as planning and execution

Basic Qualifications

Bachelor’s degree and 2 years of industry Quality Control or Quality experience

OR

Associate’s degree and 6 years of industry Quality Control or Quality experience

OR

High school diploma / GED and 8 years of industry Quality Control or Quality 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, ThermoFisher Sample Manager, LabWare, Benchling, etc.).

Advanced proficiency in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).

Experience in the use of other industry systems such as Veeva & Empower.

Experience in testing or with processes involving analytical methods.

Excellent problem-solving capabilities and attention to detail.

Experience of collaboration within 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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