QA Associate - Bioanalytical

Pharma Medica Research Inc.; Canada; On-site; CAD 45,000 - 65,000; Full time

Job summary

A Contract Research Organization is seeking a QA Associate in Mississauga, Ontario. The role involves preparing and conducting audits for compliance with GLP and GCP regulations, ensuring quality objectives are met and supporting all PMRI divisions. Candidates should have a relevant degree, excellent communication skills, and the ability to work in a team environment. A competitive compensation and benefits package is offered.

Benefits

Competitive compensation plan

Fully paid benefit plan

Opportunities for advancement

Employee Milestones Awards Program

Corporate Discounts Program

Qualifications

• 0-3 years of experience in quality assurance, quality control or laboratory role.
• Good understanding of Health Canada, FDA, EU, ICH GLP and GCP regulations.
• Ability to multi-task and keep organized.

Responsibilities

• Prepare and conduct audits of bioanalytical and laboratory activities.
• Audit final study reports for compliance with GCP.
• Report findings to management and ensure corrective actions are implemented.

Skills

Organizational skills

Problem-solving skills

Teamwork

Written and oral communication

Education

B.Sc. degree or Post-Secondary Diploma in scientific, healthcare, or pharmaceutical field

Tools

MS Office

Job description

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 are currently looking for a QA Associate to join our team in Mississauga, Ontario!

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 is 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
• 0-3 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

We offer:

• Competitive compensation plan
• 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.