Senior Specialist, Operation, Qa For Manufacturing
aerzteforum.info
Shop floor quality oversight
Gmp documentation review
Deviation investigation
Perform shop floor quality oversight for cell therapy products to ensure batch manufacturing compliance with approved procedures and GMP requirements
Job Summary
Perform shop floor quality oversight for cell therapy products to ensure batch manufacturing compliance with approved procedures and GMP requirements.
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 approved procedures and GMP requirements.
Skills & Requirements
Must-have
Shop floor quality oversight
GMP documentation review
Deviation investigation
Batch record review
Product and material release
Utility and facility oversight
Continuous improvement initiatives
Nice-to-have
Ownership and urgency
Collaboration and continuous improvement mindset
High-stakes, inspection-ready environments
Problem solving and decision making
Key Requirements
5+ years in GMP cell therapy, biologics, or sterile manufacturing
Bachelor's degree in pharmacy, Life Sciences, Biotechnology or related field
Experience with autologous or allogeneic workflows preferred
Familiarity with CFDA GMP, EU GMP, PIC/S, US FDA guidance, ICH Q7/Q8/Q9/Q10, GAMP 5, ISO 14644, ISPE Baseline Guides, and data integrity