Neil Rosario

Regional Compliance Officer (GMP) at Health Canada | Santé Canada

Greater Toronto Area, Canada

About

•Excellent communication skills developed through assisting senior management, service technicians and external stakeholders •Strong ability to recognize and identify workplace risks and develop recommendations as co-chair of the Occupational Health and Safety Committee •Proficient in Microsoft Word, Excel, PowerPoint and Outlook •In-depth knowledge and experience operating/maintaining laboratory instruments which include ICP-MS, HPLC, LC-MSMS, GC-MS, UV-VIS and FT-IR

Experience

  • Health Canada | Santé Canada (7 yrs 10 mos)
    • Regional Compliance Officer (GMP)
      Apr 2024 - Present · 2 yrs 3 mos

    • Policy Officer
      Oct 2022 - Apr 2024 · 1 yr 7 mos

    • Chemist
      Sep 2018 - Oct 2022 · 4 yrs 2 mos

      •Operated and maintained LC-ICP-MS/MS for development of arsenic speciation •Operated and maintained HPLC and GC-MS systems to ensure regulatory compliance of pharmaceutical and natural health products on the domestic market •Wrote and revised Standard Operating Procedures (SOPs) and Non-Conformities (NCs) in accordance with ISO 17025 requirements

  • Nucro-Technics Inc. (Toronto, Canada Area)
    • Group Leader
      Mar 2016 - Sep 2018 · 2 yrs 7 mos

      •Effectively researched, wrote and reviewed Standard Operation Procedures (SOP’s) •Accountable for providing a high level of customer service through interacting with clients regarding test procedures, negotiation of due dates, out of specification (OOS) results, and client inquiries •Involved in conducting investigations (OOS, out of trend (OOT), deviations, corrective and preventive actions (CAPA)), and reviewing and verifying analytical results as accurate and correct •Designated as Alternative Qualified Person in Charge (AQPIC) and qualified trainer/mentor on specific instruments/procedures •Strong communication skills demonstrated in all interactions with service representatives and compliance department for requalification and repair of analytical equipment

    • Standards Coordinator
      Nov 2014 - Sep 2018 · 3 yrs 11 mos

      •Successfully ensured standards were not expired and if were approaching expiry, or had expired, contacted the appropriate party to determine appropriate disposition of the standards •Effectively located, analyzed and logged critical elements of the Certificate of Analysis and MSDS for compendia, client and in accordance with Nucro-Technics standards into the standards database •Responsible for the generation and updating of the hard copy Standards Log on a routine basis •Communicated effectively and promptly with clients and manufacturers to gather further information on the standards as well as discuss discrepancies with paperwork •Provided clarification to analysts when further information is required

    • Analytical Chemistry Analyst Level 2
      Sep 2014 - Sep 2018 · 4 yrs 1 mo

      •Effectively and efficiently tested client raw materials and finished products using various instruments such as ICP-MS, HPLC, Microwave Digestion, Karl Fisher, UV-VIS and FT-IR as per USP, BP, EP or client methods •Accurately performed various tests such as heavy metals, elemental impurities, viscosity, assay, disintegration and loss on drying •Performed method development, validation and transfer for products that involve microwave digestion and ICP-MS analysis •Wrote lab reports as per established laboratory protocols •Performed troubleshooting and maintenance of the ICP-MS and Microwave Digester

  • Germiphene Corporation (Brantford, ON)
    • Quality Control Sampler
      Sep 2013 - Oct 2013 · 2 mos

      •Effectively sampled raw materials, in-process products and finished products following established cleaning and sampling procedures •Tested packaging components and labels to ensure they met specifications •Kept records and maintained a clean sampling room in compliance with ISO 9001:2008 guidelines.

    • Research and Development Technician
      May 2013 - Aug 2013 · 4 mos

      •Formulated, produced and tested experimental batches daily for new product development and improvement •Performed titrations, pH adjustments, viscosity and density tests daily to monitor product stability and shelf life

  • Research and Development Technician at Germiphene Corporation
    May 2011 - Dec 2011 · 8 mos