Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing
Job Summary
Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing.
Investigate quality observations and deviations using root cause analysis and support change management processes through impact analyses.
Review and approve Good Manufacturing Practices (GMP) laboratory data and documentation, including protocols, methods, technical reports, procedures, sampling plans, and rework, retest, and resample instructions.
Matching Summary
Provide quality control technical support for design verifications, process validations, stability testing, and batch release testing.
Salary
Base: $106,434.00 per year; Bonus/Equity: company bonus; Benefits: comprehensive benefit program
Skills & Requirements
Must-have
pharmaceutical device testing
design verifications
process validations
stability testing
batch release testing
root cause analysis
GMP laboratory data review
analytical lab equipment
Nice-to-have
unite caring with discovery
make life better for people
give our best effort
put people first
employee resource groups
Key Requirements
Bachelor’s degree in Biotechnology, Biomedical Engineering, or related field
1 year experience with quality control laboratory operations
1 year experience with device testing
1 year experience with quality control operations for parenteral products, dry products, or pharmaceutical devices
1 year experience writing requirements documents
1 year experience developing training materials
1 year experience with Zwick, CADI, and MicroVu equipment
1 year experience with Veeva and Quality Docs
1 year experience with CGMP, 21 CFR 820, ISO13485, and EU Medical Device Directive