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I have held responsibilities that include, Production support, Root Cause and Corrective Action, MRB, Configuration management, Machine Shop Estimating, Time Study, Process Improvement, Writing Work Instructions, Supplier Process Audits and Producibility.

Manufacturing, Quality, Lead-Instructor

Ideal Companies: Sikorsky, Pratt Whitney, GE, Honey Well

Tags for this Online Resume: Manufacturing, sheets, 4 Axis, Audit, Lathes, Support, Training, Logistics, Planning, Management, Quality Engineering

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

QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC

Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits

Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer

Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology

Manufacturing and Operations Leader

Highly adept business leader with a strong track record of successful change management in manufacturing and engineering based organizations. Demonstrated ability to excel in management roles with progressive responsibility. Robust background in all areas of Operations management with over 20 years of experience focused on NPI, Lean deployment, site transfers, cost reductions, and QMS compliance. Energetic, people-oriented...

Ideal Companies: Medical Device manufactures

Tags for this Online Resume: Change Management, Coaching, Engineering, Kaizen, Leadership, Management, Manufacturing, Manufacturing Engineering, Medical Devices, Inventory Management, Business Process Improvement, Lean, Continuous Improvement, Quality System, Supply Chain, Warehousing, Process Management, Budget Management, Organizational Develpment, Servant Leadership, Cost Savings, Capital Acquisitions, Plant Leader

Lean Six Sigma Master Black Belt, Change Manager, Supplier Quality Partnership, Voice of Customer liaison, Business Quality Management Champion, Mentor, Trainer

Lead employees and management by example to Quality 4.0 excellence. Drive Quality principles into design and processes reducing inspection through managed controls. Implement and sustain process controls through lean six sigma methodology. Allow quality system metrics to demonstrate the business performance to interested parties, regulatory agencies and customers.

Ideal Companies: Abbot, Medtronic, Meggit, ITT Controls, Forrest Machine, Enersys, Boeing, Lockheed, Northrop, CPP, Valence

Tags for this Online Resume: Quality Assurance, Document Control, ISO 9001, Supply Chain, Audit, Automotive, Change Manager, AS9100, FAA Repair Station, Lean Six Sigma Master Black Belt, Project Management, Supplier Management, Problem Solver, Microsoft Office