Pharma Medica Research Inc.
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 a Quality Assurance Associate to join our QA team in our Mississauga location.
The QA Associate I (Corporate) ensures compliance of activities conducted at the Pharma Medica Research Inc. (PMRI) Laboratory/Head Office location. This position reports to the Manager, QA (Corporate) and/or designate.
Duties and Responsibilities:
- Prepare and conduct audits of the bioanalytical and laboratory activities, data and reports for compliance with Good Laboratory Practice (GLP), PMRI Corporate policies, departmental SOPs and other regulations/guidelines as deemed appropriate.
- Audit the final study report/statistics for compliance with Good Clinical Practice (GCP), PMRI Corporate policies, departmental SOPs and other applicable regulations/guidelines.
- Conduct audits of the Phase 2-4 clinical trial activities for compliance with applicable GCP regulations, departmental SOPs and other applicable regulations/guidelines.
- Report findings to the Principal Bioanalytical Investigator and/or 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, GLP, GCP and other regulatory requirements.
- Other duties as required.
Qualifications:
- B.Sc. degree, Post-Secondary Diploma in scientific, healthcare, or pharmaceutical field, or equivalent
- 2-3 years related experience (combined or equivalent) in a quality assurance, quality control or laboratory role
- Experience with MS Office software
- Good understanding of applicable Health Canada, FDA, EU, ICH GLP and GCP regulations and 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
If you are the selected candidate, you will enjoy:
- 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.
If you’re interested in this exciting opportunity, apply today!