Quality Assurance Specialist
1280 Rancho Conejo Boulevard Newbury Park, CA 91320 US
Job Description
Position Summary
The purpose of this position is to support Quality records cell therapy products across the network. This role will also own and manage deviations, CAPAs and change controls across the network.
Primary Responsibilities
- Works with organizations to own and manage deviations and CAPAs
- For internal deviations, collect information, review documentation, perform investigations and root cause analysis, identify CAPAs, facilitate product impact assessments, and author deviation investigation reports. Lead CAPA implementation, as applicable
- Own change controls: prepare materials for CCRB, facilitate/perform change assessments, author change plans and change actions, ensure closure of actions in appropriate stage, provide evidence of completed change actions.
- Maintain records to comply with regulatory requirements and cGMPs.
- Interface effectively with team members across Quality Assurance Operations, External Manufacturing, MSAT, Product Quality Leads and other functions as required. Attend and support project-related meetings as needed
- Supports other projects as directed.
- General knowledge of Technical Operations requirements.
- Understanding of cGMP requirements for lot track-trace, documentation (SOPs and execute documents), investigations and change control
- Excellent writing skills
- Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
- Excellent communication skills and strong presentation skills.
- Collaborates and works well across teams.
- Motivated with a "can do" attitude.
- A person who operates effectively in a smaller company within a matrixed organization.
- High bar personal ethics with a "patients first" value system.
Education and Professional Experience
- Bachelor’s degree and 3 years of Quality Assurance, Records Management, or Manufacturing experience
- Previous Biopharma industry experience is highly preferred (CMC, Technical Operations, or Process Development)
- Previous Deviations, CAPA and Change Control experience
- Demonstrate ability to work in a team environment to develop, implement and deliver on project goals.
- Demonstrate ability to work successfully in a nimble fast paced matrixed environment.
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
Target pay: 40-43/hr
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