Senior Specialist, Operation, Qa For Manufacturing
Vacancyz
Shop floor quality oversight
Gmp documentation review
Aseptic processing knowledge
Provides shop floor quality oversight for cell therapy products to ensure manufacturing compliance with approved procedures and GMP requirements
Job Summary
Provides shop floor quality oversight for cell therapy products to ensure manufacturing compliance with approved procedures and GMP requirements.
Leads and influences other Quality professionals to ensure consistent application of key quality systems and participates in project teams for GMP and regulatory compliance.
Actively identifies, develops, establishes, monitors, and maintains area Key Performance Indicators (KPIs) while taking action to prevent situations impacting patient safety or product quality.
Matching Summary
Provides shop floor quality oversight for cell therapy products to ensure manufacturing compliance with approved procedures and GMP requirements.
Skills & Requirements
Must-have
Shop floor quality oversight
GMP documentation review
Aseptic processing knowledge
Contamination control programs
Sterility assurance
Risk-based decision making
Nice-to-have
Continuous improvement mindset
Collaboration and ownership
High-stakes, inspection-ready environments
Patient safety focus
Key Requirements
5+ years in GMP cell therapy/biologics/sterile manufacturing
Bachelor's degree in pharmacy, Life Sciences, or Biotechnology
Familiarity with CFDA GMP, EU GMP, PIC/S, US FDA guidance
Experience with autologous or allogeneic workflows preferred