Luis Collazo-Malave
Accomplished QC professional with 20+ years of accomplishments in quality assurance, quality system, quality control laboratory (analytical, bioassay,... | Detroit Metropolitan Area, Detroit Metropolitan Area, United States
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Luis Collazo-Malave’s Emails lu****@on****.net
Luis Collazo-Malave’s Phone Numbers No phone number available.
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Luis Collazo-Malave’s Location Detroit Metropolitan Area, Detroit Metropolitan Area, United States
Luis Collazo-Malave’s Expertise Accomplished QC professional with 20+ years of accomplishments in quality assurance, quality system, quality control laboratory (analytical, bioassay, environmental monitoring and microbiology), BOH inspections, process optimization, product transfers, analytical method transfer and development, process and equipment validation, clinical trial, and new product research and development. Ability to identify cost savings opportunities and develops work methods that will improve operations. Hands on experience in the areas of regulatory compliance, technology transfer, plant capacity evaluation, process and analytical validation, equipment commissioning, process start-up and validation, process and analytical development and production management. Effective leader and motivator for an organization that encompasses multiple functions and expertise to meet ambitious goals. AREAS OF EXPERTISE • Quality Assurance Management • Quality System Management • Quality Control Laboratory Management (Analytical, Microbiological, Sampling and Packaging Component) • Organization Change Management • Analytical Technical Service • Manufacture Technical Service (API, Parenteral, and Solid Dosage Facility) • Stability Program Management • Specification Program Management (Release, Stability, Raw Material, Packaging Component, Environmental Monitoring and Compendial Specification) • Production Management (API) • Supplier and Contract Management • Safety/Regulatory Compliance • Corrective/Preventive Action • Solid Dosage, Powder, API, Dietary Supplement, Biological, Medical Devise Combo and Sterile Filing (API and Final Product) Process • Consent Decree FDA Remediation Expert (Laboratory and Production) • Facilitation • Negotiation • Customer Service • Project Management • Continuous Improvement • Data Integrity Forensic Expert • Laboratory Excellence • Team Building and Reward Recognition • Process Mapping/Six Sigma
Luis Collazo-Malave’s Current Industry Lachman Consultant Services
Luis
Collazo-Malave’s Prior Industry
Bristol Myers Squibb
|
Ivax
|
Cordis
|
Wyeth Pharmaceuticals
|
Pfizer
|
Gsk
|
Validant
|
Emergent Biodefense Operations Lansing
|
Novi Compliance Expert Nce
|
Lachman Consultant Services
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Work Experience
Lachman Consultant Services
Director
Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Novi Compliance Expert Nce
Senior Quality Control Subject Matter Expert
Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Emergent Biodefense Operations Lansing
Director, Quality Control
Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Validant
Consultant QC SME
Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Gsk
Quality Control Director
Sat Dec 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Pfizer
Technical Service Director
Sun Apr 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Pfizer
Quality System Associate Director
Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Apr 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Wyeth Pharmaceuticals
QC Associate Director
Tue May 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Cordis
QA LAboratory Director
Fri Oct 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Apr 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Ivax
Quality Laboratory Director
Thu May 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Oct 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
Bristol Myers Squibb
Tech Service Manager
Sun Jan 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Luis Collazo-Malave Email Addresses
FAQ About Luis Collazo-Malave
-
Luis Collazo-Malave is located at
Detroit Metropolitan Area, Detroit Metropolitan Area, United States -
Luis Collazo-Malave is a
Accomplished QC professional with 20+ years of accomplishments in quality assurance, quality system, quality control laboratory (analytical, bioassay, environmental monitoring and microbiology), BOH inspections, process optimization, product transfers, analytical method transfer and development, process and equipment validation, clinical trial, and new product research and development. Ability to identify cost savings opportunities and develops work methods that will improve operations. Hands on experience in the areas of regulatory compliance, technology transfer, plant capacity evaluation, process and analytical validation, equipment commissioning, process start-up and validation, process and analytical development and production management. Effective leader and motivator for an organization that encompasses multiple functions and expertise to meet ambitious goals. AREAS OF EXPERTISE • Quality Assurance Management • Quality System Management • Quality Control Laboratory Management (Analytical, Microbiological, Sampling and Packaging Component) • Organization Change Management • Analytical Technical Service • Manufacture Technical Service (API, Parenteral, and Solid Dosage Facility) • Stability Program Management • Specification Program Management (Release, Stability, Raw Material, Packaging Component, Environmental Monitoring and Compendial Specification) • Production Management (API) • Supplier and Contract Management • Safety/Regulatory Compliance • Corrective/Preventive Action • Solid Dosage, Powder, API, Dietary Supplement, Biological, Medical Devise Combo and Sterile Filing (API and Final Product) Process • Consent Decree FDA Remediation Expert (Laboratory and Production) • Facilitation • Negotiation • Customer Service • Project Management • Continuous Improvement • Data Integrity Forensic Expert • Laboratory Excellence • Team Building and Reward Recognition • Process Mapping/Six Sigma Lachman Consultant Services -
Luis Collazo-Malave currently works in the
Lachman Consultant Services -
Luis Collazo-Malave specializes in
Accomplished QC professional with 20+ years of accomplishments in quality assurance, quality system, quality control laboratory (analytical, bioassay, environmental monitoring and microbiology), BOH inspections, process optimization, product transfers, analytical method transfer and development, process and equipment validation, clinical trial, and new product research and development. Ability to identify cost savings opportunities and develops work methods that will improve operations. Hands on experience in the areas of regulatory compliance, technology transfer, plant capacity evaluation, process and analytical validation, equipment commissioning, process start-up and validation, process and analytical development and production management. Effective leader and motivator for an organization that encompasses multiple functions and expertise to meet ambitious goals. AREAS OF EXPERTISE • Quality Assurance Management • Quality System Management • Quality Control Laboratory Management (Analytical, Microbiological, Sampling and Packaging Component) • Organization Change Management • Analytical Technical Service • Manufacture Technical Service (API, Parenteral, and Solid Dosage Facility) • Stability Program Management • Specification Program Management (Release, Stability, Raw Material, Packaging Component, Environmental Monitoring and Compendial Specification) • Production Management (API) • Supplier and Contract Management • Safety/Regulatory Compliance • Corrective/Preventive Action • Solid Dosage, Powder, API, Dietary Supplement, Biological, Medical Devise Combo and Sterile Filing (API and Final Product) Process • Consent Decree FDA Remediation Expert (Laboratory and Production) • Facilitation • Negotiation • Customer Service • Project Management • Continuous Improvement • Data Integrity Forensic Expert • Laboratory Excellence • Team Building and Reward Recognition • Process Mapping/Six Sigma -
Luis Collazo-Malave speaks the following languages:
No languages available. -
Luis Collazo-Malave has prior experience in the following industries:
Novi Compliance Expert Nce , Emergent Biodefense Operations Lansing , Validant , Gsk , Pfizer , Pfizer , Wyeth Pharmaceuticals , Cordis , Ivax , Bristol Myers Squibb -
Luis Collazo-Malave has the following professional experience:
Lachman Consultant Services , Novi Compliance Expert Nce , Emergent Biodefense Operations Lansing , Validant , Gsk , Pfizer , Pfizer , Wyeth Pharmaceuticals , Cordis , Ivax , Bristol Myers Squibb . -
You can view Luis Collazo-Malave’s
LinkedIn profile at LinkedIn URL. -
Luis Collazo-Malave’s work email addresses are
[email protected] . -
Luis Collazo-Malave works at
Lachman Consultant Services
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