Quality Assurance Associate I

2 weeks ago

Ottawa, Canada OHRI Full time

The Quality Assurance Associate I will be responsible for ensuring compliance to internal regulations as well as external regulations such as cGMP, regulatory agencies and guidelines required by trial specifications. The QA associate also maintains quality systems such as document management, change control requests, and training to ensure control and quality of manufacturing processes.

**Responsibilities include**:

- Management of controlled documents (SOPs, Policies, material specifications) inventory, including periodic review and issuance
- Quality review of GMP study protocols, and study reports to ensure completeness, compliance with specifications, internal and external regulations, and good documentation practices
- Coordination of employee training program
- Investigate GMP incidents, deviations and out-of-specification or out-of-trend results and maintain a corrective action plan program
- Participate in both internal and external audits
- Maintain awareness of existing and new cGMP requirements (e.g. guidance documents)
- Facility maintenance including cleaning and environmental monitoring.

**Basic Requirements (Education/Experience)**:

- Post-secondary degree or diploma in life sciences, Biotechnology, Biochemistry, Molecular/cell Biology or extensive equivalent experience in related field.
- 1 - 2 years of laboratory experience

**Preferred Qualifications**:

- Knowledge of Health Canada, FDA and other regulatory agency guidelines
- Knowledge and understanding of common molecular biology laboratory procedures such as tissue culture, Western Blots, Immunohistochemistry, PCR, etc.
- Experience writing scientific documents such as protocols, SOPs, study reports, etc.
- Attention to detail: detail-oriented individual capable of carefully reviewing documents
- Organization and Planning: strong interpersonal, analytical and organizational skills
- Teamwork: ability to work well with inter
- and intra-department staff on various projects, documents and investigations
- Written and Verbal Communication: writing of clear and organized documents and reports
- Goal Orientation: ability to meet deadlines and plan and prioritize accordingly
- Continuous Improvement: striving for improvement of various documents and systems, capable of giving and receiving constructive criticism in respectful manner

**Contract Details**:
This is a 2-year full-time contract with the possibility of renewal

**Salary**: Min:$21.278/hr - Max:$30.747/hr

**Comments to Applicant**:
**Contact Info**:
Name: Samantha Hodgins

Title: Operations Manager

Program: Regenerative Medicine

Ottawa Hospital Research Institute

Address: 501 Smyth Road, Ottawa, ON K1H 8L6
- The Ottawa Hospital Research Institute is committed to building and sustaining a welcoming and supportive culture that promotes equity, diversity and inclusion for trainees, researchers, and staff. We are devoted to identifying and removing barriers that limit equitable access to opportunities within our organization. The Ottawa Hospital Research Institute strongly supports initiatives that encourage the participation of all groups, in particular the four groups defined in the Employment Equity Act (women, Indigenous peoples, persons with disabilities and members of visible minorities)._
- 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._

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