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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Quality Control Senior Associate
Remote, CA US
Posted: 04/08/2025
2025-04-08
2025-05-20
Employment Type:
Contract
Job Category: Quality
Job Number: 4374
Job Description
This position will, under SME supervision, execute deliverables for a project to implement the 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 company network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.
Responsibilities for the new ELN system:
Basic Qualifications
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 company network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.
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
- High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors
- 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.