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 Regulatory Compliance Coordinator
Job Posting Category: Experienced Professionals (1+ years)
Career Level: Experienced (Non-Manager)
Industry: Packaged Goods
Job Category: Quality Assurance,Regulatory
Years Experience: 1-2 Years
Job Type: Full-time
Contract Length: More than one year
Number of Positions: 1
Posting Date: October 26, 2017
Job Location:
20 Overlea Blvd.
Toronto, ON

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Job Description

Job Title: Regulatory Compliance Coordinator

Division: Quality Systems

Department: Quality Assurance

Wage Category: Annual Salary with Benefits

Report to: Director of Quality Assurance

Job Description:

The compliance coordinator identifies functions and business practices requiring compliance activities. The compliance will assist Compliance Specialist to coordinate and develops, implement, and evaluate the compliance program and monitor its implementation.

Duties and Responsibilities:

  • Write, revise and update SOPs as necessary (physical & electronic); coordinate and train departmental and related staff on updates

  • Training Update/maintain SOP and TM training records (physically in binders and electronically in system) and training matrix (electronically) except Operations Department (Production & Manufacturing)

  • Create training plans for new positions

  • Review batch records for products

  • Review SOP index and renew SOPs that are approaching expiry period after reviewing them

  • Collect and trend KPI monthly data as required (e.g. trending of rejection report, OOS, deviation report, raw material, micro testing, components, line inspection, customer complaints, change controls, trending % completion of CAPA

  • Write change controls, deviation reports and protocols if necessary

  • Execute corrective and preventive actions for closing out audit observations as directed

  • Assist in conducting pre-audit GMP inspection of the facility in preparation for customer/regulatory audits, as necessary

  • Assist to execute corrective actions for closing out audit observations as directed
  • Assist to prepare coordinate and execute quality improvement projects
  • Perform other duties as assigned

Qualifications and Skills required:

  • Bachelor of Science in Quality Assurance & Compliance
  • 1-2 years related work experience
  • Good technical writing skills
  • Detail oriented and good organization skills
  • Effective communication skills with employees across different levels
  • Knowledge of cosmetic, OTC, NHP product regulations and GMP
  • Exposure to one of the areas in manufacturing, QC or laboratory will be an asset
  • Ability to work in a team environment and independently with minimum supervision

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