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Customer Service Quality

Zion, Illinois, 60099, United States
January 12, 2017

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*** ******* **** ******** ******, IL 60096



Operations / Purchasing / Process Improvement / Compliance / MRP

Project Management / Vendor Selection / Quality / Documentation / Cost Control / cGMP

21 CFR Parts 210 & 211, Part 600, Part 610, Part 820 Quality Systems Regulations, MDD, ICH Guidelines

ISO 13485 and ISO 9001

Dedicated and resourceful supply chain / packaging manager helping manufacturers cut costs while delivering high quality products in regulated environments. Additional specialties include procurement and project management and a demonstrated record of improving customer satisfaction through attention to detail. I hold a BS in Food Science & Nutrition from Southern Illinois University and have held a C.P.M. (Certified Purchasing Manager) designation. I am a high achiever who is self-motivated and operations minded. I work well independently or as part of a team and remain calm under pressure.

Synthesizing information and making timely, correct decisions

Possessing dynamic management skills to ensure project success

Implementing proven problem solving talents, meeting tight budgets and deadlines

Ensuring stringent external and internal regulations are met


Turned around supplier quality. Department head abruptly left Searle, leaving unresolved supplier quality issues as production was increasing by 30%. Assumed additional duties, and resolved quality issues with three major suppliers. Reduced supplier non-conformance, eliminating production interruptions. Lowered defect rates.

Solved major supply issue. A supplier announced they would no longer make a critical packaging material for one of Searle’s products as production requirements were increasing. Collaborated internally to identify alternate supplier, create specifications and select new vendor. Saved $80K over previous product with no production interruption.

Streamlined packaging projects. The packaging facility was overloaded with projects, with many going nowhere and causing starts and stops in the packaging process. Used critical chain methodologies and theory of constraints to prioritize projects and tasks. Improved project completion time by average of 40%.

Reduced shipping costs through monthly auditing. TAP’s Managing Consultant’s were required to audit invoices from packaging vendor to monitor the total spend against study budgets. Paid close attention to this as overcharges occurred at times. Determined that TAP was overcharged 1000% for shipments to clinical sites. Saved $10K.

Managed key operational issues. Hired by TAP to support investigational drug supply department for Phase III study program. Manage complex packaging, labeling and distribution initiative for nine to eleven concurrent studies conducted in 22 countries, and involving 300 clinics and more than 6,000 patients.

Career History

Master Planner, Pactiv LLC (Retail / Foodservice) 2015 to July 2016. Serve as liaison between 3 manufacturing facilities for Planning and Inventory Control to plan and communicated bi-weekly requirements. Troubleshoot packaging schedule according to prescribed days of supply inventory levels. Provide support to customer service to planned customer orders and communicate delays in production schedule. Communicate bi-weekly production schedule per monthly forecasted quantities as per ERP System.

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QA Specialist III, Abbott Laboratories (Device/Diagnostics), 2014 to July 2015. Review and assess Quality Change Notifications and edit change requests prior to submission for approval within Change Request System. Assess prospective new suppliers for materials, products and services prior to addition to Approved Supplier List (ASL).

Senior Quality Engineer, Genzyme Corporation (Biotech), 2011 to July 2014. Served on Consent Decree remediation team. Work with project teams to define, document and implement compliant, operational and sustainable quality systems. Perform gap assessments on quality systems, develop implementation plans to meet company commitments to FDA. Work with project teams to successfully implement quality systems that were verified by third party auditors.

Senior Operations Specialist, Takeda Global Research & Development, 2008 to 2010. Served as operations liaison between packager and global clinical supply. Managed projects related to packaging for clinical studies, overseeing all aspects, including review for cGMP compliance and concurrence with quality unit, distribution, returns and reconciliation.

Clinical Supply Project Leader/Consultant, TAP Pharmaceutical Products, 2005 to 2008. Provided packaging and distribution oversight simultaneously for multiple clinical studies related to a Phase III drug development program. Managed critical expiration date tracking program. Oversaw shipment, returns, and 100% reconciliation of all packaged/shipped product.

Quality and Package Engineering, Manpower Professional (Abbott Laboratories), 2004 to 2005. Applied Pharma knowledge to review and revise SOPs, specifications and procedures in Change Request System. Calculated and updated manufacturing scrap factors.

Planner/Scheduler, Searle/Pharmacia/Pfizer, 1998 to 2004. Developed clinical trial project study design templates, including personnel, facilities, materials, packaging, labeling and time required. Attended planning meetings to troubleshoot challenges. Tracked key performance indicators and published metrics.

Additional: I am a gardening, cooking and photography enthusiast.

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