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Online Resumes with "Batch Disposition"
Quality Assurance Associate
Quality Bio-Pharmaceutical professional with ISO/GMP/TQM experience and strong data management in inventory control & distribution. Ability to design, develop and improve process systems. Bi-lingual in Spanish and English. Additional skills and knowledge include: Package & Labeling Design; Documentation Editing; Contract Facility Audits; Statistical Analysis; Return Destruction Processing; Charting Trending; Contract Vende...
Ideal Companies: Open to all Medical device and bio pharmaceutical companies
Tags for this Online Resume: Quality Assurance, Documentation Specialist, Inspector, Audits, Calibration, GMP, ISO, CAPA, Change Control
Clinical Quality Assurance - 20 Years of Experience - Near 02804
Tags for this Online Resume: Quality Assurance, Consulting, Compliance, Audits, Document Review, Validation, Batch Disposition, CAPA
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
