Quality Control Senior Associate
Advanced Bio-Logic Solutions Corp•Thousand Oaks, CA
1d•Hybrid
About The Position
Join a big biopharma leader to support the implementation of a fully electronic lab notebook (ELN) system. As part of the site project team, you will focus on the design, configuration, and validation of the ELN without performing laboratory testing. This is a collaborative role that involves process engineering, master data migration, document development, and system deployment activities.
Requirements
- GxP experience, with knowledge of requirements for biopharmaceutical testing
- Experience using electronic lab notebook systems (e.g., Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling)
- Advanced proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Bachelor’s degree and 2 years of industry Quality Control or Quality experience
- Associate’s degree and 6 years of industry Quality Control or Quality experience
- High school diploma / GED and 8 years of industry Quality Control or Quality experience
Nice To Haves
- Experience with additional industry systems such as Veeva and Empower
- Familiarity with analytical methods or biopharmaceutical analytical testing processes
- Strong problem-solving and attention to detail
- Collaboration experience within and across functional teams
- Excellent written and verbal communication skills
- Experience in software validation testing in a GMP environment
Responsibilities
- Participate in process engineering activities to support ELN implementation
- Facilitate the development of business SOPs, forms, and manuals for new workflows
- Engage in system requirement gathering, software configuration, and design
- Receive and verify master data for site deployment
- Coordinate ELN template development and review with site subject matter experts
- Support operational qualification (OQ) document development and review
- Execute user acceptance testing and verify successful data migration
- Review and provide input on training materials
- Support site instrument qualification planning and execution
- Facilitate creation of new SOPs, forms, and manuals aligning with updated workflows
- Participate in system requirements gathering, software setup and design
- Support and review operational qualification processes
- Review and provide feedback on training materials
- Assist in the development of training deliverables
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What This Job Offers
Career Level
Mid Level
