Data Entry Operations

** ***** *** *****

Smithfield, NC *****

Phone (*19) 631- 0279

Tracy L. Sanders

Objective: To obtain a position where I can apply my knowledge and skills that I’ve learned in the Pharmaceutical divisions to advance my career and the industry of Pharmaceutical/Biotechnology Processing.

Work History: 2020-Current KBI Biopharma, Durham NC

DSP Supervisor

Chromatography Column Operations

Assignment of daily Ops/ Scheduling work flow

Time sheet approvals

Trouble shooting of DSP process

Triage/Deviations

Performance Reviews

ASCTrac system

Batch Record Closures

Hiring Interview Board

Client consultation

2018 – 2020 Novo Nordisk DAPI-US

Manufacturing SME

FAT Work package owner

Chrome Column Operations

Operation of Delta V

JI/SOP Authoring

Tech transfers

SDDC review and data entry /Adobe DC Pro/ExCel

Upstream operations

CIP Validation

2015 – 2018 KBI Biopharma, Durham NC

Sr. II Manufacturing Associate/Lead

Operation of BPG Chromatography Columns

AXI Chrom Column

Operation of AKTA Ready Skids

Packing/CIP/assembly and Evaluation of columns

Operation of the Unicorn system

Prep of process solution buffers

Room readiness Aseptic Bulkfills

Requesting of Batch records/Logbooks and consumables

Autoclave operations

Train Associates on day to day processing

Client orientation

Deviation writing

2010– 2015 Novartis Vaccines, Holly Spring NC

Lead /Manufacturing Associate III

Train associate and new employees

Regulate workflow on daily basis

Operations of Delta V systems

Operations of Chromatography Dilution Skids

Operations of UFDF Skids

Upstream Cell Culture Operations and processing

Commissioning and Validating of new process equipment

Autoclave/Parts washer/Millipore Integrity testing operations

SIP/CIP and Pressure Testing of Bioreactors and equipment

Redline Batch records/create, revise Logbooks/initiate workflows in Atlas

DRs/CAPAs

2006– 2010 Diosynths/Shering-Plough, Morrisville NC

Lead Manufacturing Associate II

Train associate and new employees

Operations of Chromatography Skids and Columns, CM Sepharose/DEAE/Phenyl

Operations of Unicorn HETP/ASYMMETRY Evaluations

Packing/Unpacking Chroma columns

Operations of UFDF Skids

Bulkfills

SIP/CIP of equipment

DRs/CAPAs

Review Batch records

1999– 2006 Talecris Biotherapeutics Clayton NC

Senior Tech Associate I

Train associate and new employees

Operations of Chromatography Skids and Columns, CM Sepharose/DEAE/Phenyl

Operations of Unicorn HETP/ASYMMETRY Evaluations

Packing/Unpacking Chroma columns

Operations of UFDF Skids

SIP/CIP of equipment

DRs/CAPAs

Review Batch records

Fractionate IV – 1 Cell Paste

Awards/Certifications

Operator on the Spot Award

Leader Grow Management Program/Novo Nordisk/JCC

Advance Upstream/Downstream API/ NC State B-Tech

Aseptic procedure/BDS Operation/ JCC

BIO Process Technician Certification/ JCC

Technical writing Certification/ JCC

BIO Works Certification/ JCC

Millipore Certification in Tangential flow filtration/ Wake Tech

Validation/Verification Certification/ NC State B-Tech

Education

1984 – 1988 Smithfield Selma High, Smithfield NC

Summary

I feel as though I would be a great asset to this company because I have great drive, focus and determination. Most of all Integrity and I Care.

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