Position Title: Quality Control Senior Associate
Work Location: Thousand Oaks, CA 91320 (Remote/Hybrid)
Assignment Duration: 12 Months
Work Arrangement: Remote/Hybrid/On-site depending on candidate
Position Summary: Execute deliverables for a project to implement our organization’s new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.
 
Key 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

 
Qualifications & Experience:

• 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 39.00/hr.