Job Overview The Quality Assurance Senior Specialist plays a pivotal role in ensuring compliance with regulatory requirements, c GMP and industry standards., Validation and qualification of facilities, utilities, equipment computerized systems cleaning processes manufacturing processes storage areas controlled temperature units CTUs shipping are critical for this position.,c GMP manufacturing facility validation requires strong technical aptitude special knowledge Gx P regulations applicable to biologics manufacturing EU-GMP FDA ISO industry standards ISPE ASME BPE troubleshooting problem-solving formal root cause analysis Ishikawa diagrams FMEA must be demonstrated by the candidate seeking this role