Samir Taiym

Greater Chicago Area

adkbvt@r.postjobfree.com

linkedin.com/in/samir-taiym

Summary

Experienced quality professional with experience in FDA regulations, quality management systems, root cause analysis, corrective action, and continuous improvement. Experience

Member Quality Specialist II

Teladoc Health

Apr 2019 - Present (1 year 11 months +)

Manage all complaint-related activities, including investigation, issue resolution, severity assessment, and regulatory reporting.

-Successfully closed CAPA resulting in 50% increase of on-time regulatory reviews of incoming complaints.

-Wrote several macros and scripts in Salesforce and ComplianceQuest to automate closure of priority complaints.

-Developed process for hypertension monitor complaints, including investigation requirements, supplemental information, and talk tracks.

-Key Member and Subject Matter Expert in Complaints Handling Task Force responsible for reducing complaint handing time, resulting in 40% reduced handling times, $60k in monthly cost savings, and

$1million in annual cost avoidance.

Quality Assurance Specialist

Ingredion Incorporated

Aug 2016 - Apr 2019 (2 years 9 months)

Lead on various CI/Lean projects designed to improve quality documentation processes and customer experience, including:

•Implementation of Standard Work for the Quality Documentation Team to standardize processes across the group while providing transparence and insight via relevant metrics.

•Consolidation of commonly requested quality documents into a single controlled document for 500+ SKU’s in order to reduce total number of requests.

•Creation of manufacturing site assessments designed to empower quality specialists to provide efficient and accurate response in order to improve overall customer experience.

•Results 2016-2019: Average TAT for customer requests: 15 Days 7 Days; On-time response rate: 63% 93%

Worked with key accounts to align their document control systems with Ingredion’s document control systems.

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Fully integrated the document control systems of various company acquisitions with Ingredion’s systems.

Owner and manager of the GMP and Pest Control audit program, overseeing various contractors and a 12-person cross-functional audit team.

Provided support to the internal and external auditing teams by conducting internal ISO 9001 audits and external supplier audits.

Worked cross-functionally with internal customers to ensure compliance with all applicable laws, regulations, and standard.

Lab Technician (Contract)

Kinder Morgan, Inc.

Feb 2016 - Aug 2016 (7 months)

Worked collaboratively with the quality department to design and implement various analytical methods in order to secure a key contract.

QA Lab Technician

NATUREX

Feb 2015 - Feb 2016 (1 year 1 month)

Led a temperature experiment that was used to successfully argue against a 483 during an FDA audit. Updated the sample retain program in order to reduce turnaround time for complaint and return investigations.

Education

Saint Xavier University

Bachelor's Degree, Biology, General

2009 - 2014

Licenses & Certifications

HACCP - International HACCP Alliance

PCQI - Food Safety Preventive Controls Alliance (FSPCA) Skills

Quality Assurance • Project Management • Auditing • HACCP • GMP • Testing • Documentation • Food Processing • Quality Control • Hazard Analysis and Critical Control Points (HACCP) Honors & Awards

2017 Ingredion CEO Award Finalist - Ingredion Incorporated 2017

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Ingredion Digital Challenge - Ingredion Incorporated 2018

Winning proposal and presentation of Ingredion's first annual Digital Challenge Event. Samir Taiym - page 3

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