Thayanitha Mohanarajah
Toronto,ON
Summary
Detail-oriented and experienced Technical Writer with extensive experience in document creation, editing, and maintenance for project operational preparation operations. Capable of engaging with subject matter experts to ensure industry standards, such as Good Documentation Practices (GDP) and cGMP laws, are met. Seeking a challenging role that will allow me to apply my abilities in technical writing, document management, and change management procedures in a dynamic and regulated workplace.
Overview
6
6
years of professional experience
Work History
Quality Control Specialist
BlueRock Therapeutics
11.2020 - Current
- Ensured QC laboratories equipments in ready state by performing routinely equipment checks, managing calibration and repairs, collaborating with Technical Services for facilities’ repairs and upgrades, and ensuring timely closure of audit findings, deviations and CAPAs related to the lab activities.
- Facilitate and ensure seamless communication with external vendors and technicians for equipment IQ, OQ, PQ, as well as maintain and calibrate critical equipment on a routine basis.
- Managed complicated investigations, leading interdisciplinary teams to identify root causes and execute long-term CAPAs.
- Led and managed the change management process, overseeing Document Change Record Requests (DCR), Planned Events (PE), and Unplanned Events (UPE) processes within the Veeva Vault system.
- Demonstrated adaptability to effectively manage evolving assignments and priorities independently, maintaining reliability and meeting tight deadlines.
Virology Manufacturing Technician
Microbix Biosystem
03.2018 - 10.2020
- · Demonstrated consistency and aseptic technique in preparing mammalian cell stock tissue in different vessel configurations and requested confluence levels.
- · Performed Tangential Flow Filtration (TFF) to improve the purity of the desired product.
- · Effectively extracted protein from antigens using various methods specific to each antigen and executed packaging of final products utilizing aseptic technique.
- Facilitated the transfer of analytical methods for finished products and raw materials, actively contributed to supplier and contractor evaluations, and conducted risk assessments for both production and laboratory processes.
- Assisted in training new technicians, supervised them, and submitted performance reviews to direct supervisors.
- Participated in the implementing a standardized OOS investigation process , establishing networking groups across sites for complex investigation resolutions.
Education
Associate of Science - Pharmaceutical Quality Assurance
Seneca College of Applied Arts And Technology
North York, ON08.2022
Associate of Applied Science - Applied Technology - Biotechnology
Centennial College of Applied Arts And Technology
Scarborough, ON12.2017
Skills
- Records Organization and Review
- Product Inspection
- Change Control
- Documentation Review
- GMP Training
- Deviation Initiation
Languages
English
Full Professional
Timeline
Quality Control Specialist
BlueRock Therapeutics
11.2020 - Current
Virology Manufacturing Technician
Microbix Biosystem
03.2018 - 10.2020
Associate of Science - Pharmaceutical Quality Assurance
Seneca College of Applied Arts And Technology
Associate of Applied Science - Applied Technology - Biotechnology
Centennial College of Applied Arts And Technology
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