Sandra Uribe

Operations Quality Engineer at MMI

Sandra Uribe BSCHE, LSSGB has a diverse work experience in the field of quality assurance and engineering. Sandra started their career as a Quality Assurance Associate at Pfizer, where they conducted laboratory analysis for intermediate, finished products, and stability. Sandra gained knowledge in various chemist equipment and gained experience in FDA and Internal Audits.

After Pfizer, Sandra worked as a Quality Assurance Associate at Janssen, Pharmaceutical Companies of Johnson and Johnson. Here, they were responsible for laboratory analysis of raw materials and working with excipients. Sandra received training and developed skills in cGMP, cGLP, SOP, safety rules, and regulations. Sandra also had knowledge in working with the USP, EP, and ACS procedures.

Sandra then joined The Janssen Pharmaceutical Companies of Johnson & Johnson as a Quality Batch Record Auditor/Contractor. In this role, Sandra reviewed manufacturing records at all stages and ensured compliance with established metrics. Sandra also audited packaging in pharma and OTC products, reviewing batch records and performing continuous flow checks to ensure compliance with cGMP and approved procedures.

Subsequently, Sandra joined Lean Enterprise Consulting Inc/Medtronic as an Engineering Contingent. Their responsibilities included knowledge in process changes, editing operational procedures, routing, and training. Sandra also served as a peer reviewer for validation protocols and conducted POD periodic reviews.

In 2015, Sandra started working at Abbott as a Line Support Quality Engineer. Sandra reviewed and approved qualification/validation reports and provided training and education to the manufacturing team on process tools, procedures, and equipment.

After Abbott, Sandra worked as a Quality Engineer at Alcon, A Novartis Division, where they conducted non-conformance investigations in the production area. Sandra assigned and implemented CAPAs and actively participated in production meetings to improve the training process for production personnel.

From 2017 to 2021, Sandra served as a Supplier Quality Engineer at Edgewell Personal Care. Their responsibilities included completing manufacturing permits and product registration permits, conducting cGMP training for new hire orientation, and ensuring correct implementation and documentation of department SOPs.

In 2021, Sandra joined Estyle Corp., LLC as a Quality Manager, where they held responsibilities for quality management.

Prior to their current position, Sandra held the role of Quality Assurance Manager at Anchor Glass Container Corporation. Here, they were responsible for ensuring quality assurance and management.

Most recently, Sandra has joined Medical Microinstruments, Inc. as a Quality Engineer.

Overall, Sandra Uribe BSCHE, LSSGB has had a successful career in quality assurance and engineering, with experience in various industries and a strong focus on compliance and process improvement.

Sandra Uribe earned a Bachelor's degree in Chemical Engineering from the Polytechnic University of Puerto Rico, graduating in 2011. Prior to that, they obtained a degree in Science with a focus on Chemistry from the Pontificia Universidad Católica de Puerto Rico, completing their studies in 2004. In 2015, they obtained a certification as a Lean Six Sigma Green Belt from the Polytechnic University of Puerto Rico.

Links

Previous companies

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Edgewell Personal Care logo
Medtronic logo
Pfizer logo

Timeline

  • Operations Quality Engineer

    May, 2023 - present