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Quality Engineer /Manager

Location:
Raleigh, NC, 27596
Salary:
$60,000- $ 70,000
Posted:
August 05, 2010

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Resume:

Patrick Burton

Home [919-***-****] Cell [ 919-***-****]

** ***** **** ** ***********, NC 27596 [oby6v4@r.postjobfree.com]

Professional Profile

[I have been in the pharmaceutical industry for the last eleven years, gaining experience in processes which include buffer preps, precipitations and chemical additions, and make-ups. Bulk ( Formulation), and plasma suspensions, and the continued movement through the filling process. I am also familiar with the conclusion of most liquid process, either by,( Freeze Dryer )or by autoclave to assure sterility. In addition to liquid processing I have also been exposed to Solid Dose processing, and Microbial monitoring combined with the aseptic procedures that are required to eliminate the possible threat of such. Gaining supervisor experience as a Cpl in the United States Marine(1990-1994) has given me the poise to address any adverse situation with a positive solution as to acquire forward progress]

· [Monitor Autoclave system]

· [Monitor ( Freeze dryer.)]

· [Bulk Media according to pre- calculations]

· [ Set-up, and run Schenk filtering press.]

· [Set-Up and run centrifugation of Blood Plasma]

· [Performed as set up mechanic in an Filling environment.

· [Supervise 20 to 30 employees on a nightly basis. Filling /Packaging, Bulking( Formulation)

Conduct progressive disciplinary action up to termination as necessary

Assist in Cleaning Validation as to eliminate continued microbial growth.]

· [Assure that daily production schedule is met while

· [Issue all Manufacturing Directions associated with daily production]

· [Share responsibility of reducing yearly cost of operation]

· [Evaluate employee time sheet, in comparison to actual worked hours.]

Professional Experience

[Biomerieux], [Durham, NC]

[2006-Present]

[Production Group Leader ( Supervisor)]

Achievements:

· [Fill room Cleaning Validation]

· [Implemented a more proficient cleaning protocol for bulking tanks]

· [Revision of Manufacturing Directions, and Training protocol for a more user friendly system.

Responsibilities:

· [Assure that production goals are met with minimal downtime, against production schedule]

· [Monitor 20 to 30 employees from Bulking ( Formulation), Autoclave, Filling and Packaging process]

· [Issue, observe, reconciliation, and perform corrections of Production Batch Records as to be within Sop, and cGMP compliance ]

· [Liaison with production management, maintenance, and peer group leaders in order to better accommodate production goals, and reducing scrap rate.]

· Liaison with Engineering management in order to accomplish special Line expansion, and validation.

· [ Assist Microbiology Lab in the monitoring of microbial growth , in addition to performing plate contact, and air samples.

[Tyco Mallinckrodt], [Raleigh, NC]

[2004-2006]

[Set-up Mechanic]

Achievements:

· [Internal Auditor]

Responsibilities:

· [Responsible for set-up, Run, Monitor, adjust, disassemble, and clean of production Fill Room equipment]

· [Responsible autoclave of product, and equipment that came in contact with product ]

· [Responsible for all documentation associated with production, cleaning, and maintenance.]

· [Responsible for accountability of production yield in the absence of production supervisor]

[GlaxoSmithKline], [Zebulon, NC]

[2002-2004]

[Solid Dose Manufacturing Operator]

Responsibilities:

· [Issue, perform, and review Batch Records ]

· [Perform deviation ratio calculation to receive yield]

· [Operate Tablet Compression, Coating, and Printing process]

· [Assist in the Granulation, and Weigh and Dispense process ]

[Bayer Pharmaceuticals], [Clayton, NC]

[1997-2001]

[Fractionation Technician 1]

Achievements

Bayer Process Technician Training Sterile Processes( January 26, 2001)

Bayer Shutdown Training Program CMP 08/10/01

Responsibilities:

· [Issue, perform, and review Batch Records ]

· [Perform conductivity, a280 ,trial titration, and ph samples of product]

· [Operate Funda Filter system( Acetone Drying)]

· [Assist in operation of Freeze dryer system ]



Education

[ECPI TECHNICAL COLLAGE], [RALEIGH, NC]

[Computer Electronics ( Associates Degree)]

[JANUARY 1,2003]

[Durham Technical Collage], Durham,NC

[ Bio-Works Certification]

[October 2008]

United States Marine (1990-1994)

Communication Field Wireman 2512

References

References are available upon request.



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