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Shannon Stone 1016 Grant Street Phone: 641-969-3528 Mobile: 641-814-3128 E-mail: [email protected] Objectives Experienced FSQR Specialist with 16 years Quality Management experience seeking new challenges and opportunities for development.. Experience FSQR Quality Management Specialist/Supervisor (Lead Associate)(06/2004 –Present) Cargill (Eddyville, IA USA Manage supplier/vendor evaluation (SEM) & approval systems that encompasses raw materials, packaging materials, processing aids/ingredients, transportation, warehouses, etc. Manage SEM audits for current and potential external manufacturers. Participate in or independently conduct both internal and external audits at potential and current suppliers, co-manufacturers, warehouses, transportation facilities, storage facilities, etc. Create and maintain Quality Management procedures and policies to ensure compliance to government regulations and customer requirements. Perform QM activities that include: managing Master Manufacturing Records, Batch Record systems, review and release of finished products produced in Eddyville and at co-manufacturers for the Sterol Derivatives product lines. Review and approve all Management of Change (MOC's) for Eddyville including procedural creation/revisions, equipment optimization or changes, processing changes, material changes, etc. Serve as a liaison between Operations and GMP/regulatory compliance. Manage activities involving HACCP, GMP's and food safety initiatives cross-functionally in Eddyville and with other product lines as needed. Review customer contracts including requirements for GMP compliance, product specifications, shipping requirements, packaging requirements, etc. Collaborate with Product Line Managers, Customer Service, Sales Team, Operations, and Supply Chain to ensure Cargill's protected. Manage Quality Assurance Administrative Assistant. Comply with all government regulations and Cargill policies and procedures which include but are not limited to environmental, safety, HACCP, and cGMP. Develop and maintain internal auditing/verification protocols. This includes collaborating with Supply Chain and Procurement teams in Eddyville, CHN, and Cargill Corporate. Lead customer and compliance audits for Eddyville and Sterol Derivatives. Create and implement IDOCs document management system for CHN BU. Manage Document Control Systems in the continuous optimization of the QM department, including the development, maintenance, and review of Standard Operating Procedures. Train new employees and contractors in areas of HACCP, Food Safety, and GMP's. Also provide annual training to all employees.

Shannon Stone 2014 Final

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Page 1: Shannon Stone 2014 Final

Shannon Stone

1016 Grant Street Phone: 641-969-3528 Mobile: 641-814-3128

E-mail: [email protected]

Objectives Experienced FSQR Specialist with 16 years Quality Management experience seeking new challenges and

opportunities for development..

Experience

FSQR Quality Management Specialist/Supervisor (Lead Associate)(06/2004 –Present)

Cargill (Eddyville, IA USA

Manage supplier/vendor evaluation (SEM) & approval systems that encompasses raw materials,

packaging materials, processing aids/ingredients, transportation, warehouses, etc.

Manage SEM audits for current and potential external manufacturers.

Participate in or independently conduct both internal and external audits at potential and current

suppliers, co-manufacturers, warehouses, transportation facilities, storage facilities, etc.

Create and maintain Quality Management procedures and policies to ensure compliance to

government regulations and customer requirements.

Perform QM activities that include: managing Master Manufacturing Records, Batch Record

systems, review and release of finished products produced in Eddyville and at co-manufacturers

for the Sterol Derivatives product lines.

Review and approve all Management of Change (MOC's) for Eddyville including procedural

creation/revisions, equipment optimization or changes, processing changes, material changes, etc.

Serve as a liaison between Operations and GMP/regulatory compliance.

Manage activities involving HACCP, GMP's and food safety initiatives cross-functionally in

Eddyville and with other product lines as needed. Review customer contracts including

requirements for GMP compliance, product specifications, shipping requirements, packaging

requirements, etc.

Collaborate with Product Line Managers, Customer Service, Sales Team, Operations, and Supply

Chain to ensure Cargill's protected.

Manage Quality Assurance Administrative Assistant.

Comply with all government regulations and Cargill policies and procedures which include but

are not limited to environmental, safety, HACCP, and cGMP.

Develop and maintain internal auditing/verification protocols. This includes collaborating with

Supply Chain and Procurement teams in Eddyville, CHN, and Cargill Corporate.

Lead customer and compliance audits for Eddyville and Sterol Derivatives.

Create and implement IDOCs document management system for CHN BU.

Manage Document Control Systems in the continuous optimization of the QM department,

including the development, maintenance, and review of Standard Operating Procedures.

Train new employees and contractors in areas of HACCP, Food Safety, and GMP's. Also provide

annual training to all employees.

Page 2: Shannon Stone 2014 Final

Resume: Shannon Stone

Page 2

PLTP QM Super user Tester TEMPORARY ROLE (01/2010 –01/2012)

Cargill (Eddyville, IA USA

Provided solutions for requirements that did not fit in SAP.

Provided information on legacy systems for comparison to SAP.

Provided input for creation of materials.

Entered data for specifications, inspection plans, master inspection characteristics, and methods.

Approval to customer vendor lead for adding new vendors in SAP.

Approval to material master lead for reviewing new materials for adding to SAP.

QA Administrative Assistant (05/2000 –05/2004)

Cargill (Eddyville, IA USA Responsible for managing samples sent to contract laboratories including managing data, pricing,

time of completion, and reporting to information to management and appropriate personnel.

Responsible for receipt, review, and release of all bulk and non-bulk raw materials, ingredients,

and processing aids for Eddyville.

Responsible for QA record maintenance including: issuing, collecting, controlling, collating, filing,

and archiving.

Responsible for providing QA assistance in training, auditing, and documentation. Also provide

back-up coverage for QA Supervisor as needed.

Perform miscellaneous job-related duties as assigned (scanning documents, word docs, creating

and entering data into spreadsheets, provide back-up for Executive Secretary.

Education Computer Programming (1998 – 2000) Indian Hills Community College in Ottumwa IA.

Skills Strengths

Qualified SEM Auditor.

External Manufacturing and Supplier auditor experience since 2003.

Managing internal and external customer relationships.

Archer Experience, enter audit data into Archer.

SAP Implementation and live experience.

Verbal and written communication skills.

Managing conflict regarding enforcing requirements.

Great attention to detail.

Contacts within Supply Chain Sourcing, Procurement, Sales, and Customer Service.

Document Management experience: Creation, review, approval, and revision of standard

operating procedures for Eddyville and CHN/CCMNA BU.

Strong computer skills including but not limited to Microsoft Excel, Word, and PowerPoint.

Keen sense of managing priorities and meeting deadlines.

Ability to work under stress

Experience with FSSC 22000:2005 ISO/TS 22002-1:2009 and additional FSSC 22000 requirements

Experience with ICH Q7 for Active Pharmaceutical Ingredients in Europe (GMPs)

Experience with Dietary Supplement GMPs (21 CFR Part 111)

Experience with Food GMPs (21 CFR Part 110)