Essential Job Duties:
- Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
- Development and delivery of training (to operational groups)
- Delivery of training in performance of audits (basic, intermediate audit activities)
- Provide advice and guidance on aspects of quality and compliance
- Provide consultation to the operational team on quality issues
- Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
- Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
- Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Other duties as assigned by management.
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.
- 4 years in regulatory environment (experience in GXP roles)
- Experienced GxP auditor
- Able to influence QA strategy
- Ability to communicate to groups
- Knowledge of multiple operational areas
- Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios
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