QC Document Reviewer - Bioanalytical Lab

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 an experienced Quality Control Reviewer to join our Mississauga Bioanalytical Lab team!

The QC Reviewer 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 data 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 Sr. Project 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 Sr. Project 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.

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 the pharmaceutical industry

Excellent communication and interpersonal skills

Related experience and knowledge of GLP requirements and prior experience with standard operating procedures.

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.

Possess enthusiasm and effective training capabilities

Work effectively independently and as a team member

Effective organizational skills

Must be proficient in and willing to stay current with regulatory requirements and other appropriate governing body regulations and guidelines

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.