Quality Assurance Associate
3 weeks ago
Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are actively looking for exceptional and passionate individuals who want to work in a learning, innovative team. We are currently looking for a Quality Assurance Associate I (Clinic) to join our Scarborough team
The QA Associate I (Clinic) is to ensure compliance of activities conducted at the Pharma Medica Research Inc. (PMRI) Phase I Clinic location. This position reports to the Manager, QA (Clinic) and/or designate.
Duties and Responsibilities:
- Conduct audits of the Phase I clinical activities, CRFs and source documents for compliance with Good Clinical Practice (GCP), PMRI Corporate policies, departmental SOPs and other regulations/guidelines as deemed appropriate; review protocols.
- Report findings to applicable departmental management; follow-up to ensure adequate completion of corrective actions.
- Ensure QA management are kept up to date regarding audit findings/corrective actions.
- Provide input and support as required to all PMRI divisions to ensure compliance to SOPs, GCP and other regulatory requirements.
- Other duties as required.
Qualifications:
- B.Sc. degree, Post-Secondary Diploma in scientific, healthcare, or pharmaceutical field, or equivalent combination of education and related experience
- 1-3 years related experience (combined or equivalent) in quality assurance and/or related regulatory role
- Good understanding of applicable Health Canada, FDA, EU and ICH GCP guidelines.
- Works closely with all departments and personnel to ensure PMRI's quality objectives are achieved
- Ability to work within a team environment
- Very organized and able to multi-task
- Meticulous with well developed problem solving skills
- Excellent written and oral skills
- Occasional shift work on weekends/nights
- Occasional travel between PMRI locations
Why is PMRI the place for you? We offer:
- Competitive compensation plan
- Mentorship Opportunities
- A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan
- Opportunities for advancement and career progression
- A generous Employee Milestones Awards Program
- Corporate Discounts Program
- Learning Support Programs
- Friendly atmosphere, culture of learning
Please note all applications must be eligible to work within Canada.
PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.
We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.
If interested in this position, apply today Great work environment with competitive salary and benefits program.
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