Quality Assurance Data Entry
Resume:
LINDA RUMPH
**** ****** ****** . *****, ******* *3054 . ******@*****.*** . Cell:
SUMMARY OF QUALIFICATIONS
Over 10 years of combined business experience in Quality Control, Quality
Assurance, Data Entry, and Medical Records retention. Demonstrated ability
to adapt successfully with different responsibilities such as office
management, problem solving, communications, inspection of documents and
other clerical duties. Excellent leadership and persuasion skills.
ACHIEVEMENTS
> Management Recognition and Bonus for Key participation in
implementation of Residual Solvent Project
> Created, Developed and Implemented Electronic Routing system for
GMP documentation
> Appreciation Recognition for the work effort, during Lisinopril
launch
> Promoted numerous times to increasing levels of responsibilities
> Bravo Award for relieving Receptionist and completion of FDA
request
> Perfect attendance Recognition
PROFESSIONAL EXPERIENCE
TEVA PHARMACEUTICALS USA, Doral, Florida
2001-2010
Documentation Specialist II, Documentation Specialist (2004 - 2010)
Prepare change control requests including specification revision. Ensure
the accuracy and completeness of Change Request Forms, test specifications
and methods. Maintain laboratory test specifications and methods for all
marketed products in paper and electronically. Distribute and route
documents electronically to departments for approval. Update Quality
Assurance routing system for Change control. Maintain five access databases
for test specifications and methods. Review method validation technical
reports for format. Revise and write Standard Operating Procedures. Provide
administrative support to Technical Writers and Senior Management. Process
payroll using the Kronos system. Follow TEVA safety, health and
environmental policies and procedures.
Production Clerk (2002 - 2004)
Prepare and distribute official batch and packaging records to production.
Design and print bulk labels for Manufacturing and Packaging Departments.
Review and deliver completed Batch Records to Quality Assurance. Update
daily report for product traceability.
Data Entry Clerk (2001 - 2002)
Entered data for white blood cell count reports (Clozaril). Verify
accuracy of patients' status in system. Consult pharmacists to verify
accuracy of reports for Clozapine patients. Filed Documentation in a
secure location.
LINDA RUMPH PAGE 2
BAXTER ALTHIN MEDICAL, Miami Lakes, Florida 1997-2001
Final Quality Auditor II, Final Quality Auditor I
Ensured the accuracy and completeness of the Device History Record (DHR).
Performed visual inspection. Entered lot numbers and Device Configuration
Data into JD Edwards's, SAP and AS400 database for traceability reports.
Released final product to finish goods inventory. Retrieved documentation
for FDA and employee requests. Ensured that the DHR data was retained and
maintained in a secure location. Ensured all tasks were performed in
compliance with applicable standard operating procedures.
TELECTRONICS RHYTHM MANAGEMENT SYSTEMS, Miami Lakes, Florida 1994-1997
Manufacturer of Brady-Cardiac Pace Makers
Quality Support Specialist, Data Entry Specialist
Ensured the accuracy and completeness of the Device History Record (DHR).
Entered Serial numbers and lot numbers in system for traceability reports.
Released Final Product to Finish Goods Inventory. Created, maintained and
closed In-Process Nonconformance (IPN) reports electronically. Retrieved
documentation for FDA and Lawyers request. Ensured all records were
controlled, stored and could be retrieved upon request. Ensured that the
DHR data was retained and maintained in a secure location.
EDUCATION
Business Management Coursework
Miami Dade Community College, Miami, Florida
Certificate of Completion in Developing Dynamic Speaking Skills
Barry University, Miami, Florida
Certificate of Completion in Managing Front Office Operations
Beacon Career Institute, Miami, Florida
COMPUTER SKILLS
Power point . Access . Lotus Notes . JD Edwards . AS400
SAP . Oracle . Word . Excel . Kronos . Master Control
TRAINING
Current Good Manufacturing Practice Regulations (cGMP)
Getting most from Microsoft Excel Compumaster
Standard Operating Procedure Device History Record
Manufacturing Environmental Control Area
Process Documentation Training
Hazard Communication Program
Internal Audit Procedures
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