Miguel Martinez
Senior Associate IQA
- Role
- Senior Associate Incoming Quality Assurance at Amgen
- Location
- Columbus, OH, US
- LinkedIn followers
- 500 followers
About Miguel Martinez
Quality Assurance, Quality Control, Biotechnology Pharmaceuticals, Combination Products…
Experience
Senior Associate Incoming Quality Assurance
Aug 2023 — Present · US
Sampling, inspection and dispositioning all raw materials received at the facility under general supervision. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include batch record review, SOP creation & review, documentation, review & approval of minor deviations and CAPA records and batch disposition of raw materials.Responsibilities:Implement raw material sampling and inspection activities, including completion of GMP documentation to support raw material dispositionPerform raw material disposition ensuring that all quality deliverables are metProvide quality expertise & guidance and work with operations partners, supply chain and supplier quality management to resolve issues and ensure timely release of the raw materialsOwn and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and FormsOwn, investigate and approve quality records including deviations/CAPAs assuring adherence to procedural requirements and confirming assessments and evaluations of different collaborators are complete and accurate as neededFind opportunities for continuous improvement and implement improvements in partnership with other operations teamsProvide support during GMP Quality audits & inspectionsSupport Lean Transformation and Operational Excellence initiatives
Education
The Ohio State University
Bachelor of Science (B.Sc.), Biology, General
2013
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