Quality Assurance
Resume:
SAAD M. ASRAR
**** ********* **, *******, ** ****1
******@*****.*** / https://www.linkedin.com/in/saad-asrar-55802612
Goal-oriented and accomplished Engineering and Quality professional in the fields of pharmaceutical, food, medical device and industrial grade manufacturing. Experienced with engineering project management, regulatory complaince (FDA, FSIS, USDA, Health Canada, CFIA, TGA) and implementation of QMS.
Areas of Expertise Include:
Problem Solving/Root cause Investigations
Project planning and execution
Statistical Analysis using SPC/Minitab
Change Control & CAPA Management
Lean Methodology
Process capability analysis (Cpk, Ppk)
Consent Decree Remediation
FDA & USDA Regulatory Compliance (ISO 9001:2015 and ISO 13485)
PROFESSIONAL EXPERIENCE
MILACRON/CANGEN, Atlanta, GA July 2019- Oct. 2019
Quality Engineering Manager
Responsible for providing quality oversight for a manufacturing facility that produced industrial grade products (Medical tubing pipes, hose, extruded wires, cables). Directly managed a team of 4 Quality Inspectors and 5 Operational staff. Managed supplier quality relationships to facilitate Right the first time (RFT) metrics.
Implemented site wide 5S process to streamline production flow
Successfully led ISO 9001 recertification audit
Managed incoming raw material and supplier quality relationship through trending of non-conformance data, SCARs, and periodic face to face communication.
Reason for leaving: Company’s acquisition resulted in multiple lay off at the Georgia facility.
COORSTEK, Benton, AR
Engineer 2017 - 2019
Focused on complaint investigations and process optimization to produce consistent quality products (precision ceramic seals) for automotive, defense, and petroleum industries.
•Responsible for design control for products with tight tolerance
•Accomplished problem solver and project manager
•Successfully led various improvement initiatives yielding cost savings and 50% reduction in chipping of silicon carbide seals
•Responsible for OEE metric calculation
•Developed and implemented statistical quality inspections plan for routine manufacturing
•Proficient at using DMAIC process and DOE for process optimization.
•Proficient in data analysis using statistical software (Gauge R&R, control charts, capability analysis)
Reason for leaving: Moved with family as a result of excellent employment opportunity for my wife.
BECTON-DICKENSON, Broken Bow, NE 2014 - 2016
Quality Specialist II
Focused on management of documentation system (SAP) to allow product specification control and labeling artwork control for a Class II medical device manufacturing (Blood collection device/Vacutainer). Liaison between corporate quality and manufacturing site to roll out specification changes and coordinate associated training.
•SME for documentation database management to support manufacturing compliance to ISO 9001:2008 and ISO 13485
•Minimized gaps related to documentation and enhanced simplification of manufacturing forms
•Reduced documentational non-conformances (in-process records) by holding company-wide trainings and setting in place best practices for robust procedural reviews.
•Supported implementation of UDI Initiative, an industry-wide federal requirement as a QA Lead.
•Supported (wrote protocol/report and executed) various equipment and process validation activities during facility expansion and technology transfer.
BOEHRINGER-INGELHEIM / BEN VENUE LABORATORIES, Bedford, OH 2012 - 2013
Quality Assurance Auditing Specialist II
Internal Quality auditor for class II sterile injectable manufacturing plant. Responsible for process readiness and product release for highly FDA-regulated pharmaceutical company during Consent Decree remediation.
•Led problem solving to resolve quality concerns to support cGMP manufacturing, aseptic filling, and lyophilization (Freeze Drying) of sterile injectables.
•Ensured proper aseptic technique and adherence to 21 CFR parts 210 / 211 / 11 and ICH9 / Q10 by auditing and training operators on manufacturing floor.
•Supported complaint investigation and implementation of CAPAs
•Maintained adherence to regulatory requirements by auditing batch records for product disposition.
NESTLE USA, Solon, OH 2011 - 2012
Regulatory Affairs Specialist
Led labeling compliance (CFR 9 and 21) for products as required by FSIS, FDA, and CFIA (Canada) regulations.
•Facilitated new product launch by managing claims approval process through regulatory agencies
•Performed periodic product claim evaluation with cross functional teams
GNC, Greenville, SC 2008 - 2011
Quality Assurance, International Registration Specialist
Focused on product (supplements) disposition for Canadian market. Handled all matters related to testing prior to release for sale for dietary supplements..
•Worked with FDA, NHPD, and TGA for standardization and registration of GNC products.
•SME in regulations pertaining to manufacturing of dietary supplements per USP, BP, DSHEA, and EU standards.
•Delivered documentation requests for product submissions, allowing for sale of GNC products into different countries.
•Promoted international registration of GNC products by providing technical support.
ISLAMIC FOOD AND NUTRITION COUNCIL OF AMERICA, Chicago, IL 2004 - 2008
Quality Assurance Food Technologist
Provided technical analysis of food ingredients, dietary supplements, and cosmetics to ensure compliance to dietary requirement to meet the halal claim. Published popular scientific articles in the Council’s periodical journal.
EDUCATION
Master of Science (MS)
Food Science, Purdue University, West Lafayette, IN
Thesis title: Acquisition of Kinetic Constants of L. monocytogenes binding in a Resonant Mirror Optical Biosensor
Bachelor of Science (BS)
Chemistry, St. Louis University, St. Louis, MO
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