Senior Manufacturing Associate
Astrix · Thousand Oaks, CA · 2 wk ago
ManufacturingFull-time
Join a global, science-driven biopharmaceutical organization committed to quality, innovation, and improving patient outcomes. This opportunity supports manufacturing quality operations by leading deviation investigations, CAPAs, and continuous improvement initiatives in a highly regulated environment.
Pay
$30–$31/hour
Schedule
Monday–Friday, dayshift
Contract Length: Initial 12-month assignment with potential for extension
Location
Thousand Oaks, CA
Responsibilities
- Own and manage Corrective and Preventive Action (CAPA) and Effectiveness Verification (EV) records
- Lead deviation investigations and drive root cause analysis through completion
- Coordinate cross-functional teams including Manufacturing, Engineering, Process Development, Quality Control, Supply Chain, and Quality
- Develop and implement corrective actions to prevent recurrence of quality events
- Monitor CAPA progress and communicate risks, timelines, and status updates to management
- Drive continuous improvement initiatives related to investigation and quality processes
- Ensure Quality Management System (QMS) activities are completed in compliance with established procedures
- Present investigation findings and defend CAPAs during regulatory inspections and internal audits
- Prepare clear, accurate, and compliant technical documentation
- Identify and escalate quality, compliance, supply, and safety risks as needed
Requirements
Qualifications (must have one of the below):
- High School Diploma/GED plus 2+ years of related experience, OR
- Associate's degree plus 6+ months of related experience, OR
- Bachelor's degree
Skills
- Biotechnology or pharmaceutical manufacturing experience
- Experience in other regulated industries such as medical device, food manufacturing, or aerospace/aviation
- Direct experience with CAPAs, Effectiveness Verification (EV), and deviation investigations
- Experience working within regulated quality systems
- Demonstrated project management and project ownership experience
- Ability to lead cross-functional teams and manage multiple concurrent workstreams
- Excellent written and verbal communication skills
- Strong organizational skills and ability to work independently in a matrixed environment
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply.