Pharma Medica Research Inc.
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 currently looking for a Quality Control Reviewer to join our Bioanalytical Lab Team in Mississauga.
TheQC Reviewer I is responsible for compliance with Standard Operating Procedures (SOP) and Good Laboratory Practice (GLP) requirements at Pharma Medica Research Inc (PMRI), as well as, raw date verifications, preparation of analytical reports and maintenance of laboratory log sheets/books. This position reports to the Manager, QC and/or designate.
Duties and Responsibilities
- Ensure that all reports and accompanying raw data are accurate, correct and acceptable according to the study protocol and relevant SOPs. That reports and accompanying raw data are GLP compliant prior to submission to Quality Assurance (QA).
- Interact with department staff to acquire information for report writing and auditing purposes and present QA department information to staff regarding deficiencies and areas of improvement.
- Production of data tables and reports in accordance with protocols and input from Principal Bioanalytical Investigator/Laboratory Technicians using Microsoft Word and Excel.
- Follow-up on corrective action and/or answer and follow-up questions indicated on QA raw data and report audits, as well as, performing corrective action or answer inquiries indicated in sponsor review of data and/or reports.
- Inform Principal Bioanalytical Investigator/designate of deficiency relating to all bioanalytical forms and laboratory SOPs.
- Ensure sample and instrument logbooks are current, comply with GLP and SOP guidelines.
- Maintain a system for organizing laboratory files and forms.
- Assist Manager, QC and/or designate in maintaining a system for tracking, filing, managing, and archiving of all laboratory documents, raw data and reports.
- Assist in maintaining a chronological log of audits, assay validation and sample analyses, including tracking long-term stability for analytical validations.
- Ensure the Manager, Quality Control/designate is kept up to date regarding QC audits of raw data, instrumentation and calibration within the laboratory through both oral and written reports on a daily basis
- Other duties as required.
- B.Sc. in science or Community College Diploma in related field.
- Related experience and knowledge of GLP requirements and prior experience with standard operating procedures.
- Good communication skills including good English verbal and written skills
- Be computer “literate” as required by the position in the use of spread sheets, be knowledgeable in the interpretation of analytical data and statistical analyses etc.
- Able to work both independently and as a member of a team
If you’re interested in this position, apply today!
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