Training & Compliance Specialist

Audits and Inspections

• • Lead audit/inspection readiness activities including conducting routine/periodic quality assurance assessments to measure and ensure adherence of departmental processes and procedures by internal personnel and external vendors.
  • Support conduct of inspections and audits and closely collaborate with Global QA department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents, assigning roles and responsibilities for each audit/inspection.
  • Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses and resulting measures.  

CAPA Resolution

• • Drive and manage an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures.

Project Metrics and Key Performance Indicators (KPIs)

• • Implement and update standardized metrics (including but not limited to issue resolution time, start-up timelines, set up timelines for project activities and tools etc) and other KPIs.
  • Work with study teams to implement tracking of desired metrics and KPIs.
  • Monitor metrics across studies, provide trend reports, and work with relevant partners to identify potential areas for process improvements. 

Continuous Improvement

• • Work with project or functional teams to monitor lessons learned.
  • Ensures any gaps highlighted through learnings are appropriately addressed through training or process development. 

Quality System Documents

• • Lead the scheduled review of WIs and SOPs.
  • Lead the development of new SOPs and WIs as required.
  • Support identification of gaps in current procedures and support assigned team members in writing or adapting WIs and SOPs.
  • Develop, or oversee development of templates and tools to support the implementation of SOPs and WIs.  

Training

• • Review training compliance, highlight pending trainings, and support completion/file forms 239
  • Proactively work to identify unmet training needs.
  • Support creation of a departmental training curriculum.
  • Lead the creation of training materials and training implementation.
  • Lead communication efforts to ensure a common understanding around processes. 

Laboratory Assay QC (if applicable)

• • Perform and/or oversee the performance of random QC on assays performed at the laboratory.
  • Shadow laboratory technicians at the laboratory to assess quality of the work and adherence to SOPs and regulations.

Qualifications

• • The successful candidate should hold either an undergrad degree with 4-6 years of relevant experience, or a college diploma with 7-9 years of relevant experience.
  • Health Sciences, Sciences or Clinical Research specialty preferred, as well as laboratory experience if relevant. Excellent interpersonal, verbal and written communication skills. Customer focused approach to work. A flexible attitude with respect to work assignments and new learning. Ability to manage and prioritize tasks efficiently and accurately. Ability to work in a matrix environment and to value the importance of teamwork. Ability to analyze and interpret data. Attention to detail and organizational skills. Ability to work independently and take ownership of and responsibility for work assigned. IT literate. Experience with Microsoft based applications and a general knowledge of PC functions. Culturally aware and ability to think and work globally.