Quality Assurance

Sandy J. Boswell

**** ******* ****, *** ****, Jacksonville, FL 32257 804-***-**** *******@*****.***

M

otivated and technically skilled Quality Assurance professional known for accuracy, attention to detail and exceptional leadership capabilities. Backed by proven results, solid experience, and proficiencies required in a cGMP (Current Good Manufacturing Practice) regulated environment.

Key Skills & certifications

ASQ Certified Six Sigma Green Belt (Cert No 5803)

ASQ Certified Quality Improvement Associate (Cert No 3512)

Yellow Belt

Investigations

Root Cause Analysis

Corrective/Preventative Actions

Site Public Speaking Lead

FDA Regulatory compliance

Project Management – TrackWise & SAP

Accounts Payable and Payroll Processes

Safety

Cross-Functional Trainer

Computer experience to include: SAP, MasterControl, ISOtrain, eRoom, GxPharma, LabWare LIMS, TrackWise, ADP, and Microsoft Suite.

professional Experience

FAREVA (AQUIRED PFIZER’S RICHMOND LOCATION) Richmond, VA

Technical Services Specialist, 12/13 to 10/15

Supported product validation activities to ensure accuracy and consumer safety.

Authored Bulk Manufacturing and Packaging Investigations

Created Raw Material Batch Calculations for New/Revised Product Formulations

Created Qualitative/Quantitative Formula Sheets

Distributed and archived Technical Services Documents, as applicable

Customer Liaise

Assisted in Validation Studies

Team Leader, Finance, 10/11 to 12/13

Special assignment- Implemented accounts payable and T&E policies and functions at site upon acquisition by Fareva. Managed all transactions for assigned vendors

Processed invoices and check requests for payment

Resolved invoice discrepancies

Reconciliation of payments

Vendor file maintenance

Processed payroll for temporary production labor on a weekly basis. Supported full-time employees payroll, as needed

PFIZER (AQUIRED WYETH) Richmond, VA

Quality Assurance Documentation Specialist II, 12/00 to 10/11

Performed wide array of duties to ensure product safety to the end consumer, supported final product disposition of Consumer Healthcare products and oversaw Employee Safety initiatives for the Quality and Technical Services departments.

Determined the scope of investigations to determine the appropriate path forward, safeguarding timely completion of manufacturing and laboratory investigations and appropriate corrective actions

Ensured Corporate and Regulatory compliance

Authored comprehensive Site Operating Procedures pertaining to Quality

Developed and instructed site personnel on tools used in the Investigations process

Interacted with multidisciplinary functional areas

Prepared investigation metric reports

Created and maintained the Investigations and Commitment Effectiveness databases

Administered TrackWise (Investigations, Commitments, Change Controls, Audits and Observations)

Safety Committee Chairperson for Quality Operations and Technical Services

oManaged EHS initiatives to include the oversight of meetings

oScripted Safety Toolbox Talks based on current trends and incident preventions

oLed a site safety campaign initiative for OSHA VPP (Voluntary Protection Program)

Quick Prevent Team Chairperson

oEvaluated site accidents to ensure proper corrective and preventative actions were put in place.

WYETH-AYERST (PURCHASED WHITEHALL) Richmond, VA

Senior Quality Assurance Records Technician, 10/92 to 12/00

Performed review of batch records associated with Consumer Healthcare products and release of such products to the Customer.

Reviewed production batch records and documented deviations and provided recommended batch disposition

Reviewed processing changes

Continuous Improvement Team member in maximizing release efficiency

WHITEHALL-ROBINS Richmond, VA

Clerk, 10/91 to 10/92

Performed a wide range of administrative and laboratory support activities for the department and Quality manager to facilitate the efficient operation of the organization.

Maintained filing system and retrieved documents from filing system

General clerical duties including photocopying, fax and mailing

Handled requests for information and data

Maintained office and lab supply inventories

Education

AVERETT UNIVERSITY – Danville, VA

Bachelor, Business Administration – Completed May 2009

GPA 3.61

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