QA Associate (Document Review)

QA Associate (Document Review)Apex Systems is a large staffing and consulting firm and we are looking for a QA Associates with experience with QA documentation review, exposure to GMP / GDP, and a background in life sciences for one of our biotech clients in Toronto.

Client : Biotechnology companyContract / Perm & duration : 6-month contract (possibility of extension / conversion)Location : TorontoThis position will be working 100% on-site as it is required for daily responsibilitiesResponsibilities : Reviewing executed batch records and equivalent production documents, as well as assisting in closure of batch record review backlogSupporting day-to-day operations such as room release and reviewing manufacturing and equipment changeover activitiesReviewing quality events, including deviations, lab investigations, CAPAs, and change controlsSupporting document reviews, including but not limited to SOPs, COAs, protocols, and reportsWorking closely with both Manufacturing, Quality Control, and Facilities teams in any quality matterResponsible for performing quarterly walkabouts, following up on the observations, and supporting 5S excellence projectsSupporting various process improvement projects, contributing to the overall success of the GMP operations at MaRS7 and PMCRT-15 (Toronto GMP SitesKey qualifications : Undergrad or master’s degree in biological sciences, analytical chemistry, chemical engineering, biomolecular engineering, microbiology, or similar1-2 years experience in GMP industry (junior level)- Any experience in biotechnology industry is preferred but not requiredStrong knowledge on GMP and GDPStrong critical thinking skills when working on new procedures or process improvementsStrong teamwork and communication skillsStrong written and verbal communication skills and efficient in communicating to inter-disciplinary and cross-functional teamDetail-oriented individual with a passion for quality and a strong desire to contribute to a dynamic teamProactive and able to work in a fast-paced team environment while prioritizing tasks for multiple projectsFamiliar with electronic document and quality management systems (preferred but not required)