Quality Assurance Associate

6 days ago

Mississauga, Ontario, Canada Pharma Medica Research Inc. Full time

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 a
Quality Assurance Associate
to join our QA team in our Mississauga location.

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
Manager, QA (Corporate)
and/or designate.

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 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

If you are the selected candidate, you will enjoy:

  • 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.

If you're interested in this exciting opportunity, apply today

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