Under the guidance of the Quality Manager and senior Quality Assurance team members, the Quality Assurance Associate II (QAA) assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.
- Issue controlled materials and samples for GMP processes, release testing and shipments
- Draft and review controlled documents
- Participate in quality aspects of facility maintenance (calibration and maintenance plans approval, environmental/personnel microbial and particle levels)
- Actively participate in the maintenance of the change control, internal audit, CAPA, employee training, risk assessment, vendor assessment programs
- Participate in GMP non-conformances investigations and out-of-specification or out-of-trend results as per SOPs
- Perform risk assessments for non-conformance impact as well as proactively for new or potential change to procedure
- 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
- Aid Document Control department in management of controlled documents (SOPs, Policies, MBRs, material specifications) inventory, including periodic review and issuance
- Train new team members as appropriate
- Maintain awareness of GMP requirements (e.g. guidance documents)
- Explore opportunities for continuous quality system improvements, may implement these improvements
- Post-secondary degree or diploma in life sciences
- 2+ years of experience in a regulated environment.
- Knowledge of Health Canada GMP Guidelines
- Knowledge of MS Word, Excel, PowerPoint and Outlook
- Experience in applying and complying with GMP and GDP regulations, and how they apply to manufacturing sterile clinical drug products
- Knowledge of ICH, FDA, EU and other regulatory agency guidelines
- Experience working collaboratively in a team-based environment
- Excellent attention to detail
- Must demonstrate initiative and ability to work independently to resolve issues.
- Ability to work on tight deadlines
- Ability to multi-task and coordinate project activities through completion
- Experience writing and reviewing documents such as protocols, SOPs, study reports, etc.
- Experience investigating non-conformances with minimal supervision from manager, determining root cause leading to implementation of effective CAPA(s)
- Experience with identifying continuous improvement gaps in quality system, preparing plan of action and implementation of continuous improvements to fill the gap
- Experience in Microsoft Office applications
- Experience working collaboratively in a team-based environment where objectives may be different for each team
- Knowledge and understanding of common molecular biology laboratory procedures such as tissue culture, Western Blots, PCR, etc. is an asset
- Experience with performing risk assessments an asset
This is a 2- year full-time position with possibility of renewal
Salary: $ 27.687/hr. – Max: $37.559/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 II”.
Name: Liana Medynski
Title: Quality Assurance Manager
Program: Centre for Innovative Cancer Research
Ottawa Hospital Research Institute
Address: 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.