QA Associate
3 weeks ago
Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are always looking for top talent to join our amazing team Currently we are looking for a Quality Assurance Associate **to join **our Mississauga team
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 Supervisor QA (Corporate) and/or designate.
**Duties and Responsibilities**:
Your duties will include, but not necessarily be limited to:
- 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
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