POSITION LOCATION: London, ON
POSITION TITLE: Quality Assurance Associate (FT/Perm)
POSITION REPORTS TO: Director, Quality Assurance
DEPARTMENT/UNIT NAME: Quality Assurance
Responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance deliverables. Responsible for supporting the Quality Assurance department, through assisting with audit activities in support of ongoing quality improvement. Acts as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives, based upon knowledge of regulations, standards, and industry best practices.
AREAS OF RESPONSIBILITY:
Quality Assurance Implementation
- Assist in the implementation of the corporate Quality Plan.
- Identify indicators need to assess quality levels.
- Evaluate quality activities against corporate standards and regulatory requirements.
- Assist in audits (internal, site, vendor) and review peer reports.
- Facilitate the development/revision of QMS policies, SOPs, Work Instructions, standards, and training materials as required.
- Assist in the provision of guidance to departments in the interpretation of regulatory requirements
Regulatory, Ethical Conduct, and Audit Monitoring
- Remain current on and ensure internal awareness of relevant regulatory requirements, industry standards and requirements.
- Assist in the identification of QMS documents and/or training requirements to meet regulations, standards, and sponsor expectations.
- Facilitate Sponsor and regulatory inspections or audit activities.
- Identify, create, adapt, and deliver quality assurance orientation as well as department, project team and clinical site quality assurance training programs and tools.
- Monitor training compliance of the organization
Applicants must have a minimum of an undergraduate degree along with 1-5+ years of relevant experience (4-6 years of direct experience in lieu of an undergraduate degree in combination with a College Diploma in a related field). The successful candidate will possess a strong background in process improvement including stablishing/maintaining Standard Operating Procedures (SOPs). Experience in Quality Assurance or Software Development is preferred, and knowledge of Good Clinical Practice (GCP) is an asset. Must have excellent verbal and written communication skills along with an advanced level of attention to detail. Must also demonstrate strong interpersonal relationship and collaboration skills working within cross-functional teams. Successful candidates must exhibit enthusiasm, determination, and intuitiveness, and be organized, self-directed, efficiency-minded and detail-oriented, while being flexible with changing priorities and able to work in a consistently changing environment.
*Accommodations for job applicants with disabilities are available upon request