Quality Assurance Compliance Associate

1 week ago

Mississauga ON, 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 exceptional and passionate individuals who want to work in a learning, innovative team. We are currently looking for a Quality Assurance Compliance Associate to join our Mississauga team This is a one year contract position.

The QA Compliance Associate I is responsible for assisting in and performing corporate compliance activities of the Quality Assurance Department at Pharma Medica Research Inc. ( PMRI ). This position reports to the Manager, CSV & Compliance and/or designate.

Duties and Responsibilities:

  • Train PMRI staff on regulatory compliance and PMRI compliance procedures (i.E., Quality System, Privacy Polices).
  • Assist in the development, maintenance and implementation of PMRI corporate compliance training programs.
  • Administration and maintenance of applicable ePMRI applications (i.E., eSOP, eTraining,, etc.).
  • Perform internal audits ensuring compliance to SOPs and regulatory requirements.
  • Assist in the development and revision of SOPs;
    perform SOP reviews.
  • Administration of the vendor qualification program;
    maintain vendor qualification documentation.
  • Administration of training program to ensure compliance to regulatory requirements and maintenance of training documentation.
  • Act as a compliance resource by collaboratively interacting with applicable departments to create a positive and effective attitude towards regulatory compliance.
  • Maintain and control archive material (i.E., documents, study retention drugs, electronic media) including submissions, retrievals, storage, and disposal. Maintain the archive database.
  • 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 quality assurance and/or related regulatory role
  • Knowledge of applicable regulations (i.E., GLP, GCP, Privacy, 21 CFR Part 11).
  • Excellent communication and interpersonal skills
  • 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
  • Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer;
promoting accessibilityand 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.

If interested in this position, apply today Great work environment with competitive salary and benefits program.

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