Natasha R Gibson

**** ******* *********: 269-***-****

Kalamazoo, MI 49009

E-mail: nbybh2@r.postjobfree.com

OBJECTIVE

Seeking a compliant position that will facilitate my diverse experiences with pharmaceutics and academia for the mutual benefit of top-line growth and profit.

CAREER HISTORY

Pfizer (Coretech), Kalamazoo, MI 2010

QO Document Control/Stability Labeler

Transfer batch records in Preserve to be archived

Label products to be tested on different conditions

Affordable Tax and Admin Svc., Kalamazoo, MI 2009

Bookkeeper

Entered invoices into Quickbooks

Assisted with Tax preparation

Advertising through the internet

Secretarial work (copies, typing, scheduling appointments and answering phone calls)

Kept track of the budget through Excel

Corium International Inc., Grand Rapids, MI 2007-2008

Quality Assurance – Document Control Specialist

Reviewed production records to determine compliance

Approved and released product for distribution after documentation is complete

Maintained quality system library of reference material

Updated and maintained the organizations training records

Archived all documentation and made available for online viewing

Worked with other units to resolve observations so the product can be released in a timely manner

Alkermes Inc., Wilmington, OH 2006-2007

Production Planning Associate

Tracked and distributed raw materials to ensure release times met production need

Prepared a summary of rejected raw materials on a monthly basis

Tracked the bulk yield for all finished product

Coordinated and updated training for three departments

Reconciled API usage for one finish product

Used Strawman approach to update the monthly and quarterly metrics for all products on a monthly basis

Implemented and completed chain control requests

Implemented changes using the electronic change control system (ECC)

Quality Assurance Operation Professional – Filling 2006

Reviewed batch records against approved SOP’s

Reviewed and approved SOP’s, Protocols and Final Reports

Tracked batch records with the use of Excel spreadsheets for monthly metrics

Reviewed and released raw materials

Performed triage functions in the Trackwise deviation system

Reviewed and approved IQ, PQ, and OQ’s

Knowledge in an aseptic manufacturing environment

Pfizer Inc., Kalamazoo, MI 1993-2005

Quality Assurance Professional for PGRD 2004-2005

Provided GMP manufacturing support in the review and approval of clinical API manufacturing documentation

Afforded guidance during safety review meetings

Utilized the quality systems approach during deviations investigations, OOS, and product quality issues

Followed through with any deviation to ensure they were properly documented and completed

Encouraged maintenance/quality interactions to improve cGMP compliance of API facility

Strengthened improvement of equipment and instrument change control compliance

Implemented routine quality inspections of GMP API manufacturing plant

Assisting in authoring Master Batch Records for API material

Quality Assurance Technician for PGM 2003-2004

Reviewed batch records to ensure compliance with GMPs

Communicated observations in a team setting to obtain an acceptable resolution to quality deviations

Independently supported the manufacturing of specialty products

Quality Control Inspector 2001-2002

Assured compliance to government regulations and company policies through lot order creation, quality inspection report review, final line clearances, and finished product inspection

Represented QC in various process improvement opportunities

Provided support of packaging operations to increase efficiency

Followed applicable GMPs, SOP’s, IDP’s

Quality Assurance Batch Record Reviewer for KAPI 2000-2001

Reviewed batch records to ensure compliance with GMPs

Communicated observations through appropriate documentation practices

Interacted with manufacturing toward acceptable deviation resolutions

Technical Support for Third Party Manufacturing 2000

Prepared and processed packaging orders

Processed Material and Finished Goods requisition and Supply Chain Agreements

Handled various tasks simultaneously and sharpened time management skills

Assisted in data entry into Global Logistics Information System (GLIS)

Administrative Assistant, Clinical Development – Women’s Health 1993-1999

Employed filing system for all medical documentation

Coordinated face-to-face meetings and teleconferences for approximately a 50-person office

Distributed monthly newsletters

Answered multi-line phones

Prepared and issued minutes

EDUCATION AND PROFESSIONAL DEVELOPMENT

Certification

Grand Valley State University, Grand Rapids, MI

Major: Bookkeeping

Completed: April 2010

Masters of Business Administration

University of Phoenix, Phoenix, AZ

Major: Business

Graduated: April 2007

Bachelor of Business Administration

Davenport University, Kalamazoo, MI

Major: Business

Graduated: December 2003

Associates of Arts

Kalamazoo Valley Community College, Kalamazoo, MI

Major: Liberal Arts

Graduated: August 2002

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