Brittany Alston
- Role
- Manufacturing Quality Manager at Kymanox
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Brittany Alston
Brittany Alston is the Manufacturing Quality Manager at Kymanox with experience in…
Experience
Manufacturing Quality Manager
Apr 2022 — Present · Raleigh, NC, US
Manage Kymanox’s service offerings in manufacturing quality. Specifically- Oversight, review, and disposition of clinical or commercial batches via review and approval of batch records, QC data, and supporting documentation- Oversight for QMS elements, such as deviations, non-conformances, corrective and preventive actions, change management, supplier management, and other- Process and compliance observation and support (Person-In-Plant)- Quality Assurance review of technical documentation and regulatory submissions Support Kymanox service offerings in compliance, quality technical services, and quality management systems. Specifically- Audits of raw material and component suppliers, CMOs, CROs, laboratories, distributors, and specialty service providers- Gap assessments against industry regulations or standards- Design and implementation of Quality Management Systems. Development of policies or standard operating procedures. Training (internal and external)- Inspection readiness activities and participation in regulatory body inspections- Complaints and adverse event investigation and management.
Education
North Carolina State University
Biological & Agricultural Engineering, Specialization in Biotechnology
2010 — 2012
North Carolina State University
B.S, Biological Engineering, Bioprocess Engineering Concentration
2005 — 2009
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