Technical Compliance Specialist

National Resilience

  • Mississauga, ON
  • $60,000-78,750 per year
  • Permanent
  • Full-time
  • 7 days ago
A career at Resilience is more than just a job – it’s an opportunity to change the future.Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.For more information, please visitPosition Summary:The technical compliance is responsible for ensuring compliance within the FME department, setting timelines and tracking all open items to ensure deadlines are being met. This role also require close involvement in Engineering, facilities and maintenance tasks, communication with internal stockholders/SME and client for updated related to CAPA/CI/CC and EFF. The lead is expected to assist the team members in creating required technical documents, implementing CAPAs and closing records within set timelines.Major Responsibilities:
  • Evaluate new FME CAPAs, Support initiation, execution and closing of CAPAs/CIs/CCs
  • Track progress of CAPAs/CIs/CCs/EFFs and follow up with responsible individual to ensure timelines are met.
  • Support and lead trending and reporting of CAPAs/CIs/CCs/EFFs data for management reviews.
  • Present FME KPIs are QMR including WOs and CAPAs/CIs/CCs/EFFs
  • MCCP creation and updates including performing calibration assessment and FMEA as required.
  • Audit support and readiness. Including regulatory audits and internal audits.
  • SOP/WIN generation and updates
Minimum Qualifications
  • Experience in compliance, audit, or regulatory roles.
  • Knowledge of relevant guidelines and regulations (e.g., cGMP)
  • Strong organizational and documentation skills.
  • Excellent written and verbal communication abilities.
  • High attention to detail and integrity.
  • Proficient in Microsoft Office Suite and compliance management software.
Preferred Qualifications
  • Bachelor’s degree in Engineering, Science or a related field.
  • Previous experience in a technical compliance role
  • Experienced in Pharmaceutical or Biopharmaceutical industry
  • Knowledge of relevant guidelines and regulations (e.g., cGMP)
  • Strong organizational and documentation skills.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $60,000.00 - $78,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

National Resilience