Performs QC laboratory shop floor quality oversight to ensure product testing is conducted in accordance with approved procedures and in compliance with current GMP requirements
Job Summary
Performs QC laboratory shop floor quality oversight to ensure product testing is conducted in accordance with approved procedures and in compliance with current GMP requirements.
Leads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
Actively identifies, develops, establishes, monitors and maintains area Key Performance Indicators (KPI’s) as required.
Matching Summary
Performs QC laboratory shop floor quality oversight to ensure product testing is conducted in accordance with approved procedures and in compliance with current GMP requirements.
Skills & Requirements
Must-have
GMP laboratory shop floor quality oversight
QA review and approval of GMP documentation
Product quality standards establishment
Quality oversight of QC laboratory
CAPA development and implementation
Quality Risk Assessments
patient safety, quality of the product
Nice-to-have
continuous improvement mindset
high-stakes, inspection-ready environments
collaboration and ownership
deal with problems occurring in the field
Key Requirements
5+ years in GMP cell therapy, biologics, or sterile manufacturing
Proven track record in site oversight
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
Familiarity with CFDA GMP, EU GMP, US FDA guidance, ICH Q1/ Q 2 /Q5/Q7/Q8/Q9, ChP, USP, and data integrity (ALCOA+)