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 company
Contract / Perm & duration : 6-month contract (possibility of extension / conversion)
Location : Toronto
This position will be working 100% on-site as it is required for daily responsibilities
Responsibilities :
- Reviewing executed batch records and equivalent production documents, as well as assisting in closure of batch record review backlog
- Supporting day-to-day operations such as room release and reviewing manufacturing and equipment changeover activities
- Reviewing quality events, including deviations, lab investigations, CAPAs, and change controls
- Supporting document reviews, including but not limited to SOPs, COAs, protocols, and reports
- Working closely with both Manufacturing, Quality Control, and Facilities teams in any quality matter
- Responsible for performing quarterly walkabouts, following up on the observations, and supporting 5S excellence projects
- Supporting various process improvement projects, contributing to the overall success of the GMP operations at MaRS7 and PMCRT-15 (Toronto GMP Sites
Key qualifications :
- Undergrad or master’s degree in biological sciences, analytical chemistry, chemical engineering, biomolecular engineering, microbiology, or similar
- 1-2 years experience in GMP industry (junior level)- Any experience in biotechnology industry is preferred but not required
- Strong knowledge on GMP and GDP
- Strong critical thinking skills when working on new procedures or process improvements
- Strong teamwork and communication skills
- Strong written and verbal communication skills and efficient in communicating to inter-disciplinary and cross-functional team
- Detail-oriented individual with a passion for quality and a strong desire to contribute to a dynamic team
- Proactive and able to work in a fast-paced team environment while prioritizing tasks for multiple projects
- Familiar with electronic document and quality management systems (preferred but not required)
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. QA Associate (Document Review). Reviewing executed batch records...
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