Quality Assurance Medical
Resume:
Shaundra Felder
Arlington, TX 76006
***********@*****.***
SKILLS:
Mac OS X (iPages)
Create PDFs
SQL
Microsoft Office
Cognos BI
GMPharma
Chicago/MLA Style Manuals
Microsoft Dynamics AX
JD Edwards/ SAP
CMM and AutoCAD
LMS (Logistics Management System)
MIL SPEC Standard
ANSI/ASQ Z1.4
AS/400
CFR 21
EDUCATION:
Texas Tech University Lubbock, Texas
Bachelor of Science in Zoology, minor in English
Texas Tech University Lubbock, Texas
Master of Science (Coursework), Sociology
PROFESSIONAL HISTORY:
Texas Pneumatic Systems 11/2011-04/2012
Quality Control Publications Clerk
• Inspect manuals to verify their completeness
• Verify the revision level of each publication
• Purchase new or updated publications, copy and distribute publications
• Storage of all publications, maintain the publications database
HealthPoint Biotherapeutics - (Ajilon Professional Staffing-Contract) 06/2011-11/2011
QA Analyst
• Review vendor change controls and submit patient complaints for processing
• Collect data for batch record reviews and ensure timely submittal for approval
• Manage change control, customer complaint, deviations, and batch record databases
• Working understanding of data storage in relational and or flat file environments and how data is manipulated
• Outstanding written and verbal communication skills; ability to communicate with individuals at various levels within the organization and external clients in a leadership capacity
• Outstanding critical thinking, questioning, and listening skills; superior attention to detail
• Time management skills for managing multiple individual and team tasks simultaneously, while completing work within allocated time frames
• Extensive experience using Microsoft Applications: Word, Excel, and Access
Illuminated Research LLC 10/2009-04/2011
Medical Documents Editor/QC
• Ensure documents submitted for review (Clinical Study Reports, pamphlets, etc…) follow the sponsor’s style (authoring) manual, the Chicago/MLA Style Manuals, and adheres to all ICH requirements, and regulatory agency guidelines
• Utilize Structured FrameMaker to edit and assist with the publication of Clinical Study Reports that typically run thousands of pages
• Copy-editing and proofreading of complex documents to ensure consistency and conformance with grammar, punctuation, and spelling rules, as wells as AMA (American Medical Association), client, and house style guidelines
• Utilize iPages, Adobe InDesign to create forms, author and publish documents
• Verify results and conclusions are supported by the data as presented within tables, listings, and figures; ensure sources can be verified.
• Confirm bibliographic entries are properly formatted; in-text statements are supported by cited materials.
• Perform literature searches as necessary to support medical writing activities
• Upload documents to Documentum for client review and approval.
• Create TDOCs (Technical Documents)
Alcon Laboratories, Inc. (Adecco Technical - Contract) 09/2008-10/2009
Data Analyst
• Manage project to transition QA retain sample database from Microsoft Excel to MS SQL
• Data cleanse transferred information to ensure quality is maintained
• Query SQL database for accurate product profile and test dates
• Create reports in Cognos BI highlighting current product location and count
• Gather information from manufacturers and distributors to update SQL database and create reports using SSRS and Crystal Reports
QA Technician
• Inspect Gamma and ETO sterilized components for packaging integrity
• Ensure all shipping documents present and correct
• Identify and document defects when performing in-process inspections
• Determine disposition of non-conforming materials and write reports to present to management
• Study AutoCAD produced drafts of packaging components to ensure compliance before issuance to production
• Practice CAPA quality standards
• Utilize AS/400 (ARMS) to access, manage, and request materials from the warehouse
• Access GMPharma for current revisions on all standard procedures
• Adhere to all ISO 9000:2001 registration standards and operating procedures
• Utilize CMM, micrometers, calipers, and calibrated rulers to conduct incoming inspections on packaging components and medical devices
• Create profiles in SQL for domestic and international primary packaging components
• Initiate paperwork to accompany samples to various labs for analysis
• Manage all finished product delivered to the retain sample room
• Oversee the issuance of available locations for retain sample storage
Reckitt Benckiser/ formerly Adams Respiratory Therapeutics 03/2002-09/2008
Batch Record Reviewer
• Develop processes to reduce documentation errors by streamlining forms
• Write and edit SOPs, DOIs that serve as reference materials for all employees
• Interpret standard operating procedures and ensure adherence to cGMPs
• Investigate incidents by interviewing all involved parties and generating reports to explain deviation from standard procedure
• Create reports for monthly metrics
• Audit lab reports for accuracy and completeness
• Perform detail audits of all batch records (raw materials to finished and packaged product) for accuracy, legibility, and compliance with company and FDA regulations
• Use Microsoft Dynamics and JD Edwards/ SAP to reconcile raw materials and finished product
• Troubleshoot JD Edwards and Microsoft Dynamics
• Utilize Microsoft Excel and Access to manage and track all incoming, in-process, and completed batch records
• Release finished product in LMS for transport to distribution warehouse
• Ability to multi-task and prioritize work assignments
Quality Assurance Lead Auditor
• Manage projects to redesign QA inspection methods
• Inspect and document the manufacturing process from incoming components through packaging
• Generate data from in-process inspections and interpret results to all operational areas
• Lead and train a team of QA inspectors
• Assign personnel and manage group projects
• Maintain training records for all QA inspectors
• Identify and document defects when performing in-process inspections
• Utilize micrometers, calipers, and calibrated rulers to conduct incoming inspections on packaging components; determine disposition of non-conforming materials
• Collect and prepare samples for lab analysis
• Perform additional testing of product in response to adverse drug reactions
• Provide performance feedback on co-workers
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