Quality Systems Senior Associate (ELN) jobs in United States
cer-icon
Apply on Employer Site
company-logo

SPECTRAFORCE · 8 hours ago

Quality Systems Senior Associate (ELN)

SPECTRAFOR is seeking a Quality Control Senior Associate to execute deliverables for implementing a new Electronic Lab Notebook system. This role involves participating in process engineering activities and supporting various system requirements and training material development.

ConsultingCRMInformation TechnologyLegal
check
Growth Opportunities
check
H1B Sponsor Likelynote

Responsibilities

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

Qualification

GxP experienceElectronic lab notebook systemsDevelopmentValidation testingMicrosoft Office proficiencyAnalytical methods experienceProblem-solving capabilitiesAttention to detailCollaboration skillsWritten communication skillsVerbal communication skills

Required

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

Company

SPECTRAFORCE

company-logo
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.

H1B Sponsorship

SPECTRAFORCE has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)

Funding

Current Stage
Late Stage
Company data provided by crunchbase