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Quality Control Senior Associate

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

Deviation and Root cause experience
Knowledge of quality control or manufacturing
Technical writing


The Sr. Associate will assume the responsibility of a minor/major deviation Owner in Thousand Oaks (ATO) Quality Control. The individual is responsible for:
• Initiating, managing, and driving timely closure of minor and major deviation records
• Effectively documenting the description of deviating events
• Determining the appropriate scoping strategy, including tying lots, and ensuring tied lots are controlled to prevent use and distribution, as required per procedure
• Documenting the rationale for deviation designation considering the potential for patient safety and product quality impact
• Performing required event and lot tie notifications
• Identifying subject matter experts and key stakeholders to ensure thorough investigation of deviating events
• Identifying actionable root causes and negotiating effective corrective/preventive actions
• Presenting records to auditors, inspectors, and Quality management, as required
• Ensuring records are comprehensive and compliant per procedures
• Participating in the Deviation Trending Program, as required
Desired skills/behaviors include:
• Clear and concise technical writing
• Trained in root cause analysis
• Project management and organizational skills
• Working well independently, with minimal supervision, and in teams
• Quality control and/or laboratory background to facilitate thorough investigation of deviating events and potential impact to patient safety, product quality, and other critical controls
• Ability to proactively address impact of deviating events on other quality systems, such as disposition, inspection readiness, etc.
• Ability to clearly communicate status of investigations to auditors, inspectors, and Quality management
• Ability to work cross-functionally
Additional responsibilities may be assigned to support sample coordination activities including, but not limited to:
• Logging of samples in a sample management database to support product manufacturing and testing
• Issuing Certificates of Analysis for both product and raw material lots
• Assistance with the management of contract laboratory testing

Associate's degree or bachelors degree with 3 YOE outside of school

Highschool diploma and 5 YOE

"This posting is for Contingent Worker, not an FTE"


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