Mark Camacho

Compliance Associate I at CCRM
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Contact Information
us****@****om
(386) 825-5501
Location
Toronto, Ontario, Canada, CA
Languages
  • English Native or bilingual proficiency
  • French Elementary proficiency

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Experience

    • Biotechnology Research
    • 100 - 200 Employee
    • Compliance Associate I
      • Aug 2022 - Present

      • Assist with maintenance of externally facing quality management system, including materials management, vendor management, audits (internal, external, and 3rd party), and quality support for client projects.• Review of deviation investigations and change controls and implementation of corrective and preventative actions.• Assist with the maintenance of the ISO 9001 Quality Management System.• Provide support with the supplier audit program to support GMP operations.• Support and participate in audits by clients and regulatory authorities.• Assist end-users of the electronic QMS to provide training on use of quality systems, system maintenance, and other quality procedures.• Work with team members to develop, draft, and review specific documents (SOPs, specifications, etc.) in accordance with GMP regulations.• Interface with academic and industry partners to ensure meaningful engagement and collaboration.

    • Operations Associate I
      • May 2021 - Aug 2022

      • Responsible to ensure that the controlled Grade A and B manufacturing areas are clean and remain in a state of control.• Assist client in manufacturing cell and gene therapies.• Familiar with Change Controls and how to use the QMS MasterControl. • Presents updates to team and clients and provides technical expertise in team/client meetings.• Collaborates with cross-functional teams (Operations, Compliance, QA/QC, SA and Facilities) to manufacture and deliver products to clients on schedule.• Lead team for scheduling, training new team members.

    • Canada
    • Hospitals and Health Care
    • 700 & Above Employee
    • Stem Cell Technician
      • Oct 2018 - May 2021

      • Enter accurate data into ECancer Care Database in regards to patient data and charts in a timely manner• Responsible for managing lab equipment by overseeing logistical needs by shipping and receiving as needed.• Picking up and dropping off products and supplies on short notice throughout the facility• Independently oversee the lab’s Cell Disposal project in regards to expired patient’s cells • Working with confidential and private information on a daily basis • Responsible for monitoring the lab on a regular basis to ensure equipment and processes are running up to regulated standards while multitasking.• Validate new equipment and ensure it meets current standards as prescribed under the Occupational Health and Safety Act • Ensure Cryogenic LN2 tanks are operating in a safe manner

    • Research Technical Assistant
      • Sep 2015 - Oct 2018

      • Able to process patient's blood samples to harvest PBMC's for multiple studies• Daily cleaning and maintenance of the lab area and biosafety cabinets• Capable of transferring cells from -80°C to liquid nitrogen for storage• Efficient at mapping and tracking of multiple patient samples with in various databases• Perform DNA and RNA extractions as needed

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Process Technologist
      • Feb 2014 - Mar 2015

      • Familiar with the process of mixing and blending of pharmaceutical products • Ability to clean rooms with proper detergents in compliance with companies SOPs• Knowledge on filling out batch records and paperwork as needed• Proficient at collecting samples of pharmaceutical products for analysis • Familiar with the process of mixing and blending of pharmaceutical products • Ability to clean rooms with proper detergents in compliance with companies SOPs• Knowledge on filling out batch records and paperwork as needed• Proficient at collecting samples of pharmaceutical products for analysis

    • Canada
    • Research Services
    • 1 - 100 Employee
    • Protein Expression Technician
      • Apr 2013 - Aug 2013

      • Skilled in growing different bacterial cultures to express proteins of interest• Experience with purification techniques for purifying proteins• Created reports for various proteins with all growing and purification information• Adept at making various solutions and buffers for whatever process needed • Skilled in growing different bacterial cultures to express proteins of interest• Experience with purification techniques for purifying proteins• Created reports for various proteins with all growing and purification information• Adept at making various solutions and buffers for whatever process needed

    • Canada
    • Education Management
    • 700 & Above Employee
    • Resident Assistant
      • Sep 2012 - Apr 2013

      • Patrolled campus grounds during the evening to ensure the safety of the residence• Worked in an office answering calls, dealing with money and signing out items• Experience dealing with uncooperative and or difficult individuals • Crisis Management Prevention, WHMIS, Vulnerable Sector Check and First Aid CPR level C obtained in the training • Patrolled campus grounds during the evening to ensure the safety of the residence• Worked in an office answering calls, dealing with money and signing out items• Experience dealing with uncooperative and or difficult individuals • Crisis Management Prevention, WHMIS, Vulnerable Sector Check and First Aid CPR level C obtained in the training

Education

  • Fleming College
    College Diploma, Biotechnology - Technologist - Forensics
    2011 - 2013
  • Henry Street High School
    High School Diploma
    2007 - 2011

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