Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives. Come join our team!
We have an exciting opportunity for a QC Reviewer to work within our laboratory located in Mississauga, Ontario.
The QC Reviewer is responsible for ensuring 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/Principal Bioanalytical Investigator and/or designate.
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.
Produce data tables and reports in accordance with protocols and input from the 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 perform corrective action or answer inquiries indicated in sponsor review of data and/or reports.
Inform the Principal Bioanalytical Investigator and/or 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 the Manager, QC and/or designate in maintaining a system for the 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 and/or 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.
Requirements:
B.Sc. in science or Community College Diploma in related field.
2 years of related experience and knowledge of GLP requirements and prior experience with standard operating procedures.
Good communication skills including good English verbal and written skills.
Experienced with spread sheets, be knowledgeable in the interpretation of analytical data and statistical analyses.
Able to work both independently and as a member of a team.
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.
