Location:
Ubi
Salary:
Up to $3,900/month
Working Hours:
Monday to Friday, Office Hours
Key Responsibilities:
Ensure compliance with federal, state, local regulations, and internal policies.
Perform compliance assessments (e.g. process/facility inspections, equipment reviews, record audits).
Review SOPs, batch records, deviations, change controls, and CAPAs.
Support sponsor site visits, regulatory inspections, and client audits.
Recommend and help implement corrective and preventive actions (CAPA).
Conduct regulatory training sessions and maintain training records.
Perform internal facility inspections and maintain audit documentation.
Approve customer test reports and support reagent release processes.
Monitor and help correct regulatory risk areas.
Assist in audits of vendors, subcontractors, and suppliers.
Collect and analyze Quality Metrics for QMR and QMS dashboards.
Support Quality Assurance projects and continuous improvement efforts.
Provide regulatory responses and documentation for customer qualification.
Qualifications:
Min.
Bachelor’s Degree in Life Sciences or equivalent.
Min.
2 years in a Quality Assurance role.
Proficient in Microsoft Office applications.
Excellent written and verbal communication.
Strong attention to detail and organizational skills.
Ability to follow instructions and work independently.
If interested, please email me at or telegram @kellynlytan
Kellyn Fullviana
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