Greg Weilersbacher - Eastlake Quality Consulting Email & Phone Number
@eastlakequality.com
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Greg Weilersbacher - Eastlake Quality Consulting is listed as President at Eastlake Quality Consulting, a company with 1 employees, based in San Diego, California, United States. AeroLeads shows a work email signal at eastlakequality.com and a matched LinkedIn profile for Greg Weilersbacher - Eastlake Quality Consulting.
Greg Weilersbacher - Eastlake Quality Consulting previously worked as Eastlake Quality Consulting, Inc (2010 - 2014, 2018 to Present): 619-302-1411 at Bioduro and Vice President of Operations at Formex. Greg Weilersbacher - Eastlake Quality Consulting holds Master Of Arts - Ma, Neurobiology And Behavior from San Diego State University.
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About Greg Weilersbacher - Eastlake Quality Consulting
QUALITY ASSURANCE LEADERSHIP With 25 years of industry experience Greg Weilersbacher has successfully managed Quality Assurance, Quality Control, Analytical Development, Materials Management, GMP Manufacturing, GMP Facilities and Utilities Validation, and Facility Design and Construction Management in CMOs, biotechs and pharmaceutical companies. He licensed many GMP manufacturing and testing facilities through the California Food and Drug Branch, hosted FDA Pre-Approval Inspections, and has led numerous European QP inspections of GMP facilities he managed. Mr. Weilersbacher brings practical application of root causes analysis to Deviations and CAPAs and adds significant value to the execution of Supplier Qualifications, Regulatory Audit Preparation, Internal Audits, Training Systems and the evolution of a company’s Quality Systems. SERVICING: PHARMACEUTICALS, BIOTECH, and COMBO DEVICE/PHARMACEUTICAL PRODUCTS. President of Eastlake Quality Consulting Inc. focusing on start-up through large biotech/pharmaceutical companies. Provides logical and efficient Quality Systems designed to meet your unique needs.Global auditing of GMP manufacturers and laboratories for U.S. FDA and European Commission GMP compliance.Specialties: Quality Assurance Leadership, Authoring of Compliant yet Efficient Quality Systems, Auditing of Global Manufacturing and Testing Facilities, Senior QA Oversight for the Design/Construction Management/Validation of GMP Manufacturing and Testing Facilities, Performance of GAP analysis of Quality Systems, 483 Observation Remediation, Supplier Quality Agreements.Has previously held the positions of Associate Director of QA/QC and Director of Quality Assurance.
Listed skills include Gmp, Quality Assurance, Validation, Fda, and 17 others.
Greg Weilersbacher - Eastlake Quality Consulting's current company
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Greg Weilersbacher - Eastlake Quality Consulting work experience
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Eastlake Quality Consulting, Inc (2010 - 2014, 2018 To Present): 619-302-1411
President
CurrentProviding expert leadership and planning to companies seeking to obtain GMP manufacturing licensing through California Food and Drug Branch and/or pre-approval inspections by FDA.GMP Training (21 CFR 210-211), Data Integrity Training (FDA, WHO, MHRA), FDA Pre-Approval Inspection Training, Preparation of Facilities and Quality Systems for Inspection by.
Vice President Of Operations
Current- Promoted to this position by the Chief Executive Officer and President.
- Directly responsible for meeting or exceeding departmental monthly/annual revenue goals for all departments. Directly manage the projects and employees of the Analytical Development, Quality Control, Project.
- Created, implement, and manage the budgets for six departments.
- Collaboration with BioDuro sites in Beijing and Shanghai to establish Global CMC Solutions parent division contributing to the development of business strategy and focus for sites in China and the U.S. Assessed the.
Director Of Quality Assurance And Quality Control
Director Of Qa/Qc
Vp Of Quality Operations - Leads Qa, Qc, Materials Management And Gmp Facilities
Quality Assurance - Focused on continuous improvement of BioDuro's Quality Systems to meet the compliance needs of our clients and current requirements of regulatory agencies. BioDuro's QA provides internal audit and client audit support, vendor qualifications, review of GMP production batch records, review of testing data, approval of certificate of.
President
PHARMACEUTICAL & BIOTECHInterfacing with clients on a daily basis to assess their needs, developing clear and transparent project proposals, working with external contractors and manufacturing service providers to ensure projects move forward, and completing tasks on time.Design and implementation of phase-specific Quality Systems to govern raw material.
Associate Director Of Qa/Qc
Senior Leadership of Quality Departments - creating, implementing, and maintaining robust Quality Systems designed to meet the evolving needs of pre-clinical, early and late stage product development.Created and managed the Quality Control Department - reviewing and approving all QC product procedures, environmental monitoring, sterile gowning.
Director Of Quality Assurance
Successfully lead-hosted a six-day FDA inspection of Pharmatek for the PAI for two client pharmaceutical products.Senior management supervision of 14 successful European QP inspections of Pharmatek's manufacturing and laboratory facilities.Senior management supervision for all client audits of the Pharmatek facility (40 to 60 audits per year).Design.
Quality Assurance Manager
Design, construction management, validation and licensing of two Class 100,000 (ISO 8) manufacturing suites and support areas (Pharmatek's Oberlin Drive facility) for use in GMP manufacturing of solid oral dosage forms.Authored Pharmatek's Facility and Validation Master Plans.Provide Quality Assurance consulting services to Pharmatek clients for phase.
Quality Assurance Manager
Performed all external audits for Corvas including vendors used for metrology, analytical testing, stability storage, bulk drug manufacturing, final drug product fill and finish sites, product label and packaging operations, and clinical supply distribution.Reviewed and approved all clinical packaging label proofs and final labels, randomization codes.
Quality Assurance Auditor Iii / Training Coordinator
Quality Assurance Auditor Ii / Training Coordinator
Research Associate - Analytical Chemistry
Senior Research Assistant - Analytical Chemistry
Research Assistant
Assisted in the development of reversed-phase and strong cation exchange HPLC assays.Integration and statistical analysis of data.
Analyst I
Method validation and statistical analysis of data.Co-authored technical reports and protocols.Conducted HPLC assays.
Graduate Research Assistant
Research Assistant
Neuroimaging and analysis of histological data.Animal surgery, histology, and animal behavior testing
Greg Weilersbacher - Eastlake Quality Consulting education
Master Of Arts - Ma, Neurobiology And Behavior
Bachelor Of Arts - Ba, Neurobiology And Behavior
Frequently asked questions about Greg Weilersbacher - Eastlake Quality Consulting
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What company does Greg Weilersbacher - Eastlake Quality Consulting work for?
Greg Weilersbacher - Eastlake Quality Consulting works for Eastlake Quality Consulting.
What is Greg Weilersbacher - Eastlake Quality Consulting's role at Eastlake Quality Consulting?
Greg Weilersbacher - Eastlake Quality Consulting is listed as President at Eastlake Quality Consulting.
What is Greg Weilersbacher - Eastlake Quality Consulting's email address?
AeroLeads has found 1 work email signal at @eastlakequality.com for Greg Weilersbacher - Eastlake Quality Consulting at Eastlake Quality Consulting.
Where is Greg Weilersbacher - Eastlake Quality Consulting based?
Greg Weilersbacher - Eastlake Quality Consulting is based in San Diego, California, United States while working with Eastlake Quality Consulting.
What companies has Greg Weilersbacher - Eastlake Quality Consulting worked for?
Greg Weilersbacher - Eastlake Quality Consulting has worked for Eastlake Quality Consulting, Bioduro, Formex, La Jolla Biologics, and Pharmatek.
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What schools did Greg Weilersbacher - Eastlake Quality Consulting attend?
Greg Weilersbacher - Eastlake Quality Consulting holds Master Of Arts - Ma, Neurobiology And Behavior from San Diego State University.
What skills is Greg Weilersbacher - Eastlake Quality Consulting known for?
Greg Weilersbacher - Eastlake Quality Consulting is listed with skills including Gmp, Quality Assurance, Validation, Fda, Sop, Capa, Glp, and Quality System.
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