Quality Assurance Specialist (Product Complaints)
Quality Assurance Specialist (Product Complaints)
L5
Industries
Research and Development in BiotechnologyBiological Product ManufacturingIn-Vitro Diagnostic Substance Manufacturing- Monitor and triage the product complaints inbox daily and escalate critical complaints as appropriate
- Record, track, process, and close product complaints within the complaint management system
- Manage follow-up activities to help ensure complaints are closed in a timely manner
- Coordinate with internal teams and external vendors/CMOs regarding complaint investigations and outstanding information
- Perform complaint-related reconciliation activities with vendors
- Maintain complaint tracking logs and other assigned Quality records
- Support complaint trending and periodic metrics as needed
- Assist with audit or inspection-readiness activities as needed
- Bachelor's degree required
- Approximately 2-5 years of relevant QA experience within biotechnology, pharmaceutical, or medical device environments
- Previous experience supporting product complaints, complaint handling, or a closely related Quality function
- Strong attention to detail and organizational skills
- Comfortable managing routine, detail-oriented work with a high volume of follow-up and documentation
- Strong written and verbal communication skills
- Ability to work effectively with cross-functional teams and external vendors
- Experience using electronic Quality/document management systems preferred
- San Diego-area candidates preferred, but fully remote candidates will be considered
Level
SeniorL5
Location
Everett, WA
Occupation
Quality Control Analysts
Industry
Research and Development in Biotechnology
Posted
yesterday
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