Senior Specialist, Operation, Qa For Manufacturing
Trzdev35
Shop floor quality oversight
Gmp documentation review
Aseptic processing knowledge
Perform shop floor quality oversight for cell therapy products to ensure batch manufacturing compliance with GMP requirements and approved procedures
Job Summary
Perform shop floor quality oversight for cell therapy products to ensure batch manufacturing compliance with GMP requirements and approved procedures.
Lead and influence other Quality professionals to ensure consistent application of key quality systems and participate in project teams for GMP and regulatory compliance.
Proactively participate in company initiatives for continuous improvement, providing guidance and delivering timely results while contributing to quality system improvement.
Matching Summary
Perform shop floor quality oversight for cell therapy products to ensure batch manufacturing compliance with GMP requirements and approved procedures.
Skills & Requirements
Must-have
Shop floor quality oversight
GMP documentation review
Aseptic processing knowledge
Contamination control programs
Risk-based decision making
Patient safety focus
Nice-to-have
Continuous improvement mindset
High-stakes environment comfort
Collaboration and urgency
Key Requirements
Bachelor's degree in pharmacy, Life Sciences, Biotechnology
5+ years in GMP cell therapy/biologics/sterile manufacturing
Experience with autologous or allogeneic workflows
Familiarity with CFDA, EU, PIC/S, US FDA, ICH, GAMP 5, ISO 14644, ISPE
Data integrity (ALCOA+) knowledge
PMP, Lean Six Sigma, or GAMP qualifications preferred