Quality Assurance Engineer

Tajuna Copeland

***** ****** **. * *******, Illinois 60411l 773-***-****)l

*********@***.***

Profile

Experienced professional with a solid technical background familiar

with ICH Guidelines, strong emphasis on Technical Writing, Validation

Quality, Regulatory Compliance and Quality Assurance.

1. Strong Scientific, Technical and Analytical Background

2. Extremely Detail Oriented

3. 15 years combined experience in Pharmaceutical Validation and

Quality Assurance

4. Maintains a positive and professional attitude with peers and co-

workers

Employment

US Census Matteson IL

Crew Leader 4/10 - 7/10

Responsible for the planning and direction of 17 enumerators,

currently conducting the follow-up of the 2010 Census

Responsible for daily fact-checking, payroll and administrative

duties

MonoSol RX - Aerotek Contractor Portage, IN

Validation Technician

9/08 - 8/09

In cGMP pharmaceutical facility specializing in film manufacturing:

5. Track and trend data for facility HVAC and USP Water systems

6. Update and maintain all validation documentation ie. Equipment

Master Files, Equipment Operation Manuals and PM schedules

7. Perform Gap Analysis of aged validations, update, execute and close

them out

Abbott Laboratories- Manpower Contractor Abbott Park,

IL

Medical Writer 1/06 - 12/07

8. Writing manufacturing formulas for assays used to standardize

diagnostic instruments and equipment

9. Initiating Change Requests and Design Change Requests which allow

new products to be manufactured

Validation Quality Engineer 8/03-

1/06

10. Initiating Amendments for Process Validations

11. Writing and Redlining Manufacturing Formulas

12. Conducting Technical Review of Chemical Characterizations for

Change Requests

13. Auditing client Change Point Analysis against competitors data

14. Researching Chemical and Drug compositions for compatible

compositions

8/00 - 1/02

15. FDA Response: Review and approve Product Remediation Binders, in

conjunction with Quintiles Consulting, for compliance with FDA

consent decree

16. Review and approve SOFTWARE IQ/OQ/PQ deliverables

17. Review and approve EQUIPMENT IQ/OQ/PQ protocols and reports in

compliance with cGMP

18. Participate on Cross-Functional Teams to develop

validation/qualification strategies

Tajuna Copeland

20061 Marlin Ct. l Lynwood, Illinois 60411l 773-***-**** l

*********@***.***

Quintiles Consulting (Affiliate)

Validation Specialist 2/02 - 7/03

Works with clients in the pharmaceutical, medical device, biologic and

biotechnology industries to develop quality assurance and regulatory

strategies for compliance with FDA regulation by:

19. Initiating change control procedures

20. Conducting assessments of client studies, and procedures to

determine compliance

21. Technical review of clients standard operating procedure against

manufacturer inserts

22. Assisting with the development and implementation of quality

systems, validation programs and document control methodologies

23. Developing and implementing corrective action plans to address

deficiencies

24. Writing and executing protocols and writing summary reports.

Viskase Corporation Bedford Park, IL

Quality Control Inspector 1989 - 1998

25. Write and amend company standard operating procedures for a company

manufacturing cellulose meat casing

26. Coordinate and perform internal audits for company ISO 9002

Certification

27. Calibrate instruments and equipment

28. Responsible for drafting training materials and training new

employees

29. Perform routine chemical testing and data analysis

Relevant Training

30. Computer System Software Validation Training focused on 21 CFR Part

11

31. ISO 9001 and ISO 9002 Policies, Procedures and Audits

32. Abbott certified as a Validation Quality Engineer, specializing in

and Facilities, Utilities and Equipment Validation and Software

Validation emphasizing 21CFR 820

Instrument/Equipment Familiarizations

Amino Acid Sequencer Reach-in Coolers,

Freezers, Incubators

Total Organic Carbon Analyzer UV-Vis

Spectrophotometer Analytical Balance

Liquid Chromatography

Centrifuge Abbott X-System

Instruments

33. Chemical Titrator HVAC

34. EtO Sterilizer Infrared Moisture Meter

Brookfield Viscometer Mettler Toledo Lab X

Education

B.S Biology-Chemistry 5/2000 Dominican University - River

Forest IL

Software Familiarizations: MS Word, Excel, Lotus 1-2-3

Certifications/Service Affiliations: ISO 9002 Auditor, Certified Nursing

Assistant

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