Manager Engineer

**** ********** ***. 864-***-**** ***************@*****.***

Michael Smith

Document Control ISO/FDA Experience

Coordinator, Maintaining documentation to ISO standards 13485:2003 and

Span Packaging FDA part 21 CFR Part 211, FDA 21 CFR Part 820

Greenville SC Presenting for ISO/FDA auditors

(Aug 09- Oct 14) Retrieved Documentation and support for other ISO/FDA

presenters

Storage and retrieval of previous revisions of policies

and procedures and maintenance records as per FDA/ISO

guidelines

Preparing and Issuing of Packaging and Manufacturing

Batch Records

Writing instructions according to customer specifications

and manufacturing capabilities

Working with Department Managers and Customers to make

necessary changes

Writing/Issuing of Validations/Verifications

Documenting required specifications for machines and

products

Provide specifications when needed for audits

Calibrations

Performed monthly calibrations/verifications on

lab/production equipment (scales, thermometers, timers,

data-loggers, calipers, etc)

Maintained Calibration records in Microsoft access

database

Auditor

Performed internal audit of departments for continual

improvement and to comply with GMP standards

Performed external audits of external suppliers

Consumer Complaint Coordinator

Investigating complaint of products manufactured

Provide a written response to customer

Track/Trend complaints for potential issues

Implement corrective action as necessary

Water System Management

Responsible for day to day running of USP water system

Make minor repairs when necessary

Office Supply Manager

Responsible for keep all office supplies in stock,

ordering special item when necessary

Accountable for staying within monthly allotted budget

Meet vendors for taking quotes on supplies

Quality Inspector

Inspecting finished product as it comes off production

line

Stopping line if product is not to specifications

Administrative Administrative Engineer

Industrial Responsible for turning in monthly costing reports to

Engineer, corporate

Milliken & Recording waste daily waste of raw materials

Company Providing information relating to costing of finished

Marietta, SC product

(Dec 94-Jun 09) Maintained weekly quality information for trending

potential problems

Worked on production floor as PI (Process Improvement

Manager)

Work on committee to determine proper PPE (Personal

Protective Equipment) necessary for specific duties.

Assistant Assistant Manger

Manager Responsible for bi-weekly payroll of store

Radio Shack, Handling customer complaints

Easley, SC Maintaining monthly sales quotas

(July 89-Dec 94) Making weekly schedules for associates

Performing quarterly inventory

Evaluating and reporting associate production.

Education Associates Greenville Technical 2005

Degree in College, Greenville, South

Management, Carolina

Accounting

References References are available on request.

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