Experience

New Beta Innovation Canada Limited

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Specialist

  • Jun 2022 - Present

  Review QMS documents such as but not limited to deviations, CAPA’s, Investigations, change controls, alarms, excursions, etc. Review GMP documents including but not limited to sop’s, batch records, qualifications protocols, studies, reports, etc. Create and revise QMS SOP’s as required. Perform document control activities such as but not limited to issuance, reconciliation, archival, number assignment and formatting of GMP documents. Performing routine training coordinator duties and support in improvement of company’s GMP training program. Perform routine line clearance checks and QA oversight on manufacturing, aseptic filling and packaging functions. Ensure regular GMP compliance on the production floor. Prepare and review media fill, process validation, and cleaning validation documentation and provide oversight as required. Perform data collection and development of statistics for monthly and quarterly management review meetings. Participate in internal and external audit activities as assigned. Collaborate and work closely with all departments to maintain quality culture. Show less



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Systems Specialist

  • May 2021 - Jul 2022

• Quality Systems Documentation Specialist

  • Apr 2020 - May 2021

• BioCork2 project Quality Systems Documentation Specialist

  • Sep 2019 - Apr 2020

• Technical Operations

  • Mar 2018 - Sep 2018

  -Cleaning and process validation. -Review, approval and updating of relevant documentation. -Implemented 5S methodologies for cleaning items onsite. -Analysing cleaning data to reduce cleaning cycle times. -Created and implemented cleaning process boards for each piece of manufacturing equipment onsite. -Cleaning and process validation. -Review, approval and updating of relevant documentation. -Implemented 5S methodologies for cleaning items onsite. -Analysing cleaning data to reduce cleaning cycle times. -Created and implemented cleaning process boards for each piece of manufacturing equipment onsite.