Evaluates responses to inspection reports and performs follow-up with respondents,
management, or others, if needed, to ensure resolution
Report on relevant quality metrics (for multiple topics/departments) and highlight trends
Provide consultation to the operational team (e.g. as they revise/write controlled documents)
Delivery of training in performance of audits (basic, intermediate audit activities)
Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
Contribute to local Quality initiatives and process improvement initiatives aimed at improving
compliance and/or efficiency of the local QA organization
Create and/or re-write QA SOPs based on findings from local quality initiatives.
Organizing, Prioritizing and Managing all aspects of workload to meet business needs.
Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated
in applicable controlled documents, are followed
Perform other duties as assigned by management.
A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science
Experience may be substituted for education
4 years in regulatory environment (experience in GXP roles) and willingness to
Knowledge of industry quality systems/standards and able to apply (applicable) regulations in
order to monitor compliance
Experienced GxP auditor
Experienced in process improvement
Clear communication skills, including ability to provide clear feedback
Able to clearly articulate processes in order to provide training
Able to influence process improvement initiatives / offer solutions
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