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Work Background
ALKUSenior Manager, TC Strategy
Apr. 2023Andover, Massachusetts, United StatesLiaison to Revenue, communicate between Revenue Management and Training Centers, and create and update the process for ALKU’s Training Centers. Work with every Training Center on retainment, engagement, offer acceptance
ALKUVirtual Training Center Manager
Sep. 2021 - Apr. 2023Andover, Massachusetts, United StatesALKU is a specialized consulting services firm based in Andover, Massachusetts, focused on deploying highly skilled consulting resources through five main brands: Government, Life Sciences, ERP, HCIT, and Security
One of ALKU’s main priorities is not only developing its current employee’s but also giving College students the opportunity to learn more about the industry, our business and discovering their inner talent. The Andover Virtual Training Center gives students a chance to work in the office or remote if they are located at a University that is not local to an ALKU location. ALKU is focused on not only in hiring entry level talent, but also helping grow and enlighten students throughout their education. If you have any questions in regards to ALKU or our Training Center's, please feel free to email me at mking@alku.com.
ALKURegional Training Center Manager - Harrisonburg
Jun. 2019 - Sep. 2021Harrisonburg, VAALKU is a specialized consulting services firm based in Andover, Massachusetts, focused on deploying highly skilled consulting resources through three niche-focused divisions: ALKU Technologies, ALKU Quality and ALKU Government Solutions. One of ALKU’s main priorities is not only developing its current employee’s but also giving College students the opportunity to learn more about the industry, our business and discovering their inner talent. The Regional Training Center’s give students the opportunity to work while going to school and help them build the foundation of sound career at ALKU. ALKU is focused on not only in hiring entry level talent, but also helping grow and enlighten students throughout their education. If you have any questions in regards to ALKU or our Regional Training Center's, please feel free to email me at mking@alku.com.
ALKUPharmaceutical Account Manager
Jun. 2017 - Jun. 2019Andover, MAHere at ALKU, I focus on providing high level, talented experts within the areas of quality and compliance, regulatory affairs, and validation serving Medical Device, Pharmaceutical, and Biotechnology companies nationwide. With an unmatched standard of excellence, I make it my mission to ensure that every client meets FDA standards and resolves any and all compliance issues. It is my duty to build upon the relationship between my clients and ALKU beyond the formalities of a contracted placement to reach a new level of partnership. Through these relationships and delivery of quality resources I have effectively driven success in Quality Assurance, Validation, Regulatory Affairs, Remediation’s, Quality System Improvements and Project Management. Keywords/Specialties: Quality Compliance, Validation, Regulatory Affairs, Biotechnology, Pharmaceuticals, Quality Engineering, Recruiter, FDA Rules & Regulations, Quality Assurance / Engineering, Recruiter, GMP/GCP/GLP/QS Audits, Quality Systems implementations, process improvement, SOP red-lining/creation, work instruction and procedures development, ISO 13485 implementations/upgrades, Batch Records Review, Complaint Handling, CAPA, Adverse Event, and MDR process improvements and remediation, DMR/DHF Remediation, Mock FDA Audits, MO/Supplier Audits, FDA regulatory submission preparation/review, Regulatory Compliance training, Regulatory Filings, 510(k) Submissions, LE Mark, PMA Submissions, NDA, IDE, IND, Regulatory Strategy, Technical Files, MVP Development, Process and Product Validation Computer Systems Validation (CSV)- (ERP, LIM, QS Software, Training Software, etc.), Equipment Validation, Facilities and Utilities Validation, IQ/OQ/PQ Protocol Development and Execution
ALKUPharmaceutical Recruiter
Jun. 2016 - Jun. 2017Andover, MAHere at ALKU, I focus on providing high level, talented experts within the areas of quality and compliance, regulatory affairs, and validation serving Medical Device, Pharmaceutical, and Biotechnology companies nationwide. With an unmatched standard of excellence, I make it my mission to ensure that every client meets FDA standards and resolves any and all compliance issues. It is my duty to build upon the relationship between my clients and ALKU beyond the formalities of a contracted placement to reach a new level of partnership. Through these relationships and delivery of quality resources I have effectively driven success in Quality Assurance, Validation, Regulatory Affairs, Remediation’s, Quality System Improvements and Project Management. Keywords/Specialties: Quality Compliance, Validation, Regulatory Affairs, Biotechnology, Pharmaceuticals, Quality Engineering, Recruiter, FDA Rules & Regulations, Quality Assurance / Engineering, Recruiter, GMP/GCP/GLP/QS Audits, Quality Systems implementations, process improvement, SOP red-lining/creation, work instruction and procedures development, ISO 13485 implementations/upgrades, Batch Records Review, Complaint Handling, CAPA, Adverse Event, and MDR process improvements and remediation, DMR/DHF Remediation, Mock FDA Audits, MO/Supplier Audits, FDA regulatory submission preparation/review, Regulatory Compliance training, Regulatory Filings, 510(k) Submissions, LE Mark, PMA Submissions, NDA, IDE, IND, Regulatory Strategy, Technical Files, MVP Development, Process and Product Validation Computer Systems Validation (CSV)- (ERP, LIM, QS Software, Training Software, etc.), Equipment Validation, Facilities and Utilities Validation, IQ/OQ/PQ Protocol Development and Execution
ALKUQuality Recruiter
Jun. 2015 - Jun. 2016Andover, MAHere at ALKU, I focus on providing high level, talented experts within the areas of quality and compliance, regulatory affairs, and validation serving Medical Device, Pharmaceutical, and Biotechnology companies nationwide. With an unmatched standard of excellence, I make it my mission to ensure that every client meets FDA standards and resolves any and all compliance issues. It is my duty to build upon the relationship between my clients and ALKU beyond the formalities of a contracted placement to reach a new level of partnership. Through these relationships and delivery of quality resources I have effectively driven success in Quality Assurance, Validation, Regulatory Affairs, Remediation’s, Quality System Improvements and Project Management. Keywords/Specialties: Quality Compliance, Validation, Regulatory Affairs, Biotechnology, Pharmaceuticals, Quality Engineering, Recruiter, FDA Rules & Regulations, Quality Assurance / Engineering, Recruiter, GMP/GCP/GLP/QS Audits, Quality Systems implementations, process improvement, SOP red-lining/creation, work instruction and procedures development, ISO 13485 implementations/upgrades, Batch Records Review, Complaint Handling, CAPA, Adverse Event, and MDR process improvements and remediation, DMR/DHF Remediation, Mock FDA Audits, MO/Supplier Audits, FDA regulatory submission preparation/review, Regulatory Compliance training, Regulatory Filings, 510(k) Submissions, LE Mark, PMA Submissions, NDA, IDE, IND, Regulatory Strategy, Technical Files, MVP Development, Process and Product Validation Computer Systems Validation (CSV)- (ERP, LIM, QS Software, Training Software, etc.), Equipment Validation, Facilities and Utilities Validation, IQ/OQ/PQ Protocol Development and Execution
USA Auto GlassOffice/Marketing Manager Intern
May. 2012 - Sep. 2012Naples, FloridaTravel within three counties (Lee, Collier and Charlotte) calling on Insurance Agents and companies with fleet vehicles to introduce USA Auto Glass services to market the company and increase sales. • Responsibilities include: o Trade-show management o Pricing RFQ’s o Order Management o Purchasing raw materials o Enter Receivables and Payables into corporate finance system
Plymouth State UniversityFellow of the Outreach Specialist Program
Feb. 2012 - May. 2015Plymouth State UniversityAs the Fellow for the Tele-Counseling program, I will manage a group of seven students who contact prospective PSU students in order to raise admissions at PSU. We have incorporated a system which will allow us to contact students that show interest in our school. It will be my duty to create relevant lists of students to call using SalesForce. I will also be responsible for ensuring that all Tele-Counselors espouse PSU values to all of the students contacted.
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