Quality Assurance Specialist
- Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).
- Review new regulations and assess for impact on the business.
- Identify documents requiring an update to ensure compliance.
- Propose updates and obtain agreement on the recommended changes.
- Review new and updated Quality Agreements for impact.
- Highlight the issues and concerns and work with the other QA area managers to assess the potential impact.
- Work with team to redesign the Quality Agreements for all areas, including API and drug product manufacturing internally and at a Third Party Manufacturer, Finishing, Analytical testing, device development.
- Update other monthly metric review slides as requested.
- Conduct trials (facilitate) for new processes as requested.
- Assemble packages of manufacturing and regulatory items for Project Managers to conduct country approval as requested.
Experience & Education:
- A minimum of 4+ years experience in Quality Assurance or related field.
- Preferred healthcare industry and specific experience in quality function.
- Strong understanding of US and international regulations for quality systems and compliance.
- Effective use of oral and written communication skills to clearly communicate the actions necessary to resolve issues.
- Bachelor s degree or equivalent experience is required; typically in life sciences or engineering.
- BS degree or 3-7 years equivalent experience.
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