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Experienced Quality Assurance Manager in the Pharmaceutical Industry along with some valued years of cross-over experience as a Production Manager in both Device manufacturing Focus Factory and the Plastic Pour Bottle Irrigation Solutions Filling Focus Factory with a proven track record of providing the leadership and management practices in numerous areas to maximize reliability, efficiency to support business operations. Strong advocate of continual process improvement and demonstrated the leadership to be successful during my career. Extensive experience in operations, CAPA , critical thinking/problem solving, and continuous improvement in an FDA regulated environment.
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Quality ManagerViking Range, Llc Apr 2023 - PresentGreenwood, Mississippi, Us -
Career TransitionCareer Break Mar 2023 - Apr 2023
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Production Manager Ii (Solutions- Plastic Pour Bottle/Iv Glass)Baxter International Inc. Jun 2021 - Mar 2023Deerfield, Illinois, UsManage, provide technical support, and coordinate activities and projects of the Solutions Factory assuring compliance with established standard, and financial goals. The focus factory includes plastic pour bottle blow molding, plastic pour bottle filling/packing, steam sterilization, glass IV injectable filling and packing. -
Production Manager Ii At Baxter International Inc. (Devices)Baxter International Inc. Mar 2020 - Jun 2021Deerfield, Illinois, UsManage, provide technical support, and coordinate activities and projects of the Devices Focus Factory assuring compliance with established standard, and financial goals. The Devices are mainly reconstitution devices for Baxter and OEM customers.
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Quality Manager Ii (Devices/Injection Molding)Baxter International Inc. Nov 2011 - Mar 2020Deerfield, Illinois, UsManage, provide technical support, and coordinate activities and projects of the devices/injection molding Quality Operations,assuring compliance with established standards and regulations.• Manage complaint evaluations, exceptions, CAPA, procedures and associated audits assuring compliance to all governmentregulations, company policies and procedures. Assure the safety and quality of the products, processes, and systems.• Audits, creates, and implements changes to specifications and SOPs. Accountable for adequacy of specifications and SOPs toassure all product meets the requirements for safety, adequacy, and efficacy. Responsible for on- going self-audit program of plantmanufacturing and quality operations for assigned areas of responsibility.• Financial responsibilities and accountabilities include: department and capital budgeting and expenditures for areas ofresponsibility.• Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures alreadyestablished by the company.
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Interim Quality Director, Baxter Healthcare CorporationBaxter International Inc. Jul 2017 - Apr 2018Deerfield, Illinois, UsResponsible for the Quality Operations of the Entire Plant
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Quality Manager I ((Sets/Trays/Tubing Extrusion/Sterilization/Supplier Quality)Baxter International Inc. Feb 2007 - Nov 2011Deerfield, Illinois, UsManage, provide technical support, and coordinate activities and projects of the sets/trays/tubing Quality Operations, assuringcompliance with established standards and regulations.• Manage complaint evaluations, exceptions, CAPA, procedures and associated audits assuring compliance to all governmentregulations, company policies and procedures. Assure the safety and quality of the products, processes, and systems.• Manage all the activities related to Supplier Quality, EO/Gamma Sterilization.• Audits, creates, and implements changes to specifications and SOPs. Accountable for adequacy of specifications and SOPs toassure all product meets the requirements for safety, adequacy, and efficacy. Responsible for on going self-audit program of plant manufacturing and quality operations for assigned areas of responsibility.• Financial responsibilities and accountabilities include: department and capital budgeting and expenditures for areas ofresponsibility.• Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures alreadyestablished by the company.
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Quality SupervisorBaxter International Inc. Sep 2001 - Feb 2007Deerfield, Illinois, UsQuality Supervisor in Solutions Filling and Devices
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ChemistBaxter International Inc. Dec 1995 - Sep 2001Deerfield, Illinois, UsMixing and finals chemist
Michael Hackney Skills
Michael Hackney Education Details
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Delta State UniversityNatural Sciences -
Delta State UniversityChemistry
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Delta State UniversityGeneral
Frequently Asked Questions about Michael Hackney
What company does Michael Hackney work for?
Michael Hackney works for Viking Range, Llc
What is Michael Hackney's role at the current company?
Michael Hackney's current role is Quality Manager.
What is Michael Hackney's email address?
Michael Hackney's email address is mi****@****ter.com
What is Michael Hackney's direct phone number?
Michael Hackney's direct phone number is +166258*****
What schools did Michael Hackney attend?
Michael Hackney attended Delta State University, Delta State University, Delta State University.
What skills is Michael Hackney known for?
Michael Hackney has skills like Quality System, Gmp, Medical Devices, Validation, Fda, Quality Assurance, Pharmaceutical Industry, Cross Functional Team Leadership, Manufacturing, Change Control, Lean Manufacturing, Six Sigma.
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