- Issue controlled materials and samples for GMP processes, release testing and shipments
- Coordination of employee training program
- Assess vendors for GMP materials and services
- Draft quality documents
- Participate in quality aspects of facility maintenance (calibration and maintenance plans approval, environmental/personnel microbial and particle levels)
- Maintain awareness of existing and new GMP requirements (e.g. guidance documents)
- May participate in and maintain change control program
- May participate in both internal and external (government or client) audits
- May perform quality review of GMP study protocols, amendments, experimental data, and study reports to ensure completeness, compliance with specifications, internal and external regulations, and good documentation practices
- May investigate GMP non-conformances and out-of-specification or out-of-trend results and maintain CAPA program
- Explore opportunities for continuous quality system improvements
- Post-secondary degree or diploma in life sciences, or equivalent experience in related field.
- Understanding of Health Canada GMP Guidelines.
- Excellent abilities to use MS Word, Excel, PowerPoint and Outlook
- Excellent attention to detail
- Strong interpersonal, analytical and organizational skills
- Ability to work well with inter- and intra-department staff on various projects, documents and investigations; assist team members as needed
- Excellent written and verbal communication skills. Must have the abilities to present written documents and reports; consult with team members when presented with a challenge
- Excellent ability to meet deadlines and plan and prioritize day to day work.
- 1 - 2 years of laboratory experience
- Experience in applying and complying with GMP, GLP, GDP, GCP regulations
- Knowledge of Health Canada, FDA and other regulatory agency guidelines
This is a 2- year full-time contract with possibility of renewal
$ 20.651/hr. – Max: $29.844/hr.
Comments to Applicant:
Please send your cover letter and resume as a SINGLE PDF. Email subject lines AND document name must be written as: “Last Name, First Name –QA Associate”.
Quality Assurance Manager
Centre for Innovative Cancer Research
Ottawa Hospital Research Institute
501 Smyth Road, Ottawa On, K1H 8L6
We thank all applicants for their interest. However, only those invited for an interview will be contacted. The Ottawa Hospital Research Institute is an equal opportunity employer. Upon request, accommodations due to a disability are available throughout the selection process.