Quality Control Associate

Quality Control Senior Associate - ELN Implementation (GxP Environment)

Location: Thousand Oaks, CA (Hybrid)

Schedule: Monday to Friday, standard business hours

Compensation: $40–$44 per hour (based on experience)

Join a big biopharma leader to support the implementation of a fully electronic lab notebook (ELN) system within a GMP-regulated environment. As part of the site project team, you will contribute to the design, configuration, validation, and deployment of the ELN platform without performing laboratory testing. This collaborative role focuses on process engineering, master data migration, documentation development, system validation, and cross-functional coordination to ensure successful site adoption.

• Participate in process engineering activities supporting ELN implementation and workflow redesign
• Facilitate development of business SOPs, forms, and user manuals aligned with new digital workflows
• Gather system requirements and support software configuration and design activities
• Receive, verify, and support migration of master data for site deployment
• Coordinate ELN template development and review with site subject matter experts
• Support operational qualification (OQ) document development and review activities
• Execute user acceptance testing (UAT) and verify successful data migration
• Review and provide input on training materials and change management deliverables
• Support site instrument qualification planning and execution activities

Top Skills (Must-Haves):

• GxP experience in biopharmaceutical testing or quality environments
• Experience with electronic lab notebook (ELN) systems (e.g., Biovia One Lab, Thermo Fisher Sample Manager, Lab Ware, Benchling)
• Advanced Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint)

Required Experience &

Skills:

• Strong understanding of GxP requirements within biopharmaceutical testing environments
• Experience supporting ELN or laboratory system implementation projects
• Ability to contribute to system validation, user acceptance testing, and documentation review
• Strong attention to detail and problem-solving skills
• Experience collaborating across cross-functional teams
• Excellent written and verbal communication skills

Preferred:

• Experience with additional industry systems such as Veeva or Empower
• Familiarity with analytical methods or biopharmaceutical analytical testing processes
• Experience in software validation testing within a GMP-regulated environment

• Facilitate creation and revision of SOPs, forms, and manuals aligned to updated ELN workflows
• Participate in requirements gathering, system setup, and configuration activities
• Support operational qualification documentation and validation efforts
• Review and provide feedback on training materials and deliverables
• Assist in development of training and change management materials

Ready to support digital transformation and ELN implementation in a GMP-regulated QC environment? Apply now to take the next step in your career.