Shevonda Spence - Wade

Quality System Specialist-APR at Endo Pharmaceuticals

Location
Huntsville, Alabama Area
Industry
Pharmaceuticals

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Shevonda Spence - Wade's Overview

Current
Past
  • Lead Analyst at Abbott Laboratories
  • Manufacturing Specialist II at Abbott Laboratory
  • QA/QC Analyst at KV Pharmaceutical Company
Education
Connections

206 connections

Shevonda Spence - Wade's Summary

Independent, precise, goal oriented, and success-driven professional.
Effective with high levels of responsibility in fast-paced, high-volume work environments.
Detail oriented and committed to quality excellence in all facets of job performance. Able to
consistently meet assignment deadlines and maintain accurate records.

Shevonda Spence - Wade's Experience

Quality System Specialist-APR

Endo Pharmaceuticals

Public Company; 1001-5000 employees; ENDP; Pharmaceuticals industry

May 2013Present (1 year 5 months) Huntsville, Alabama Area

•Author of comprehensive Annual Product Reports; production history, analytical and product lot data, trending and product performance assessment.
•Review of each manufacturing process and changes to assess trends and determine if specification or production procedures changes are needed.
•Review of each non-conformance reports, laboratory investigations, and customer complaints reports for impact to the overall product process.
•Generate and assess manufacturing, finished product and stability data trends.
•Communicate to cross functional groups within the quality organization any obvious trends that occur during the products annual review period.
•Served as Project lead for Audit Observations within the Organizational Learning & Development Group and Quality Systems Group.
•Served as Project lead for realigning training procedures for several cross functional quality and manufacturing groups.
•Experienced in updating existing Standard Operating Procedures and Identify gaps to streamline the procedural process to step-wise-instruction for clarity.

Public Company; 1001-5000 employees; ENDP; Pharmaceuticals industry

September 2010May 2013 (2 years 9 months) Huntsville, Alabama Area

•Provide analytical support for new and existing raw material product.
•Review supplier Certificate of Analysis to ensure manufacture results complies with company’s specifications, as well as author Certificate of Analysis and reports.
•Review current methods and certificate of analysis to ensure procedures are performed per USP guidance’s.
•Initiate, draft and edit standard operation procedures (SOP’s) to ensure regulatory compliance, guidelines and regulations.
•Review laboratory notebooks to ensure proper documentation procedures are followed as per companies’ compliance policies.
•Perform a variety of test analyses and qualification of new products in support of the development of solid and oral dosage form generic drug products.
•Lead and coordinate analytical projects associated the use of HPLC, Dissolution and any other analytical techniques applied to the testing of pharmaceutical drug substances, products, and excipients.
•Fully understands the requirements of cGMP, USP, ICH and other associated Regulatory requirements.
•Experience with immediate release, extended release, or modified release products.
•Mentor and train entry level scientists.
•Performed analytical test by HPLC, dissolution (USP App1 and 2), and various methods for wet chemistry analysis.

Analytical Chemist

Missouri Analytical Inc.

December 2009August 2010 (9 months)

•Perform analytical test by HPLC, GC, dissolution (USP App 1 and 2), solvent extraction, and various methods for wet chemistry analysis.
•Performed instrument calibrations on HPLC (Waters), Dissolution Baths (Vankel and Hanson) and other analytical equipment.
•Proficient in analyzing data in Empower, data integrators, and multiple forms of calculations as per the USP.
•Serves as the company’s trainer for the Empower 2 software data system.
•Developed a training program for new and existing employees for the Empower 2 software data system.
•Proficient in current USP, ACS, EP, JP and ICH guidance documents.

Research Chemist

Covidien

Public Company; 10,001+ employees; COV; Medical Devices industry

November 2005July 2009 (3 years 9 months)

•Performed exploratory clinical research for NDA and ANDA’s products for potential new products.
•Served as a group leader for multiple projects for the controlled substance data management system.
•Initiated and coordinated the biannual controlled substance audits and maintained the controlled substance database system for the pharmaceutical research development business group.
•Served as a liaison between the analyst and management for the controlled substance database system.
•Communicated with cross functional groups to collected and compile data for internal audits.
•Analytical group leader for multiple projects.
•Validated non-compendia and compendia methods for the pharmaceutical imaging quality control/quality assurance business group.
•Evaluated test results for trending purposes.
•Proficient in drafting protocols and reports for method validation procedures.
•Provided analytical support for new and existing dosage form products in R&D.
•Proficient in drafting reports/ investigation/deviation/nonconformances.
•Performed gap analysis for various analytical methods and instrumentation.
•Proficient in analytical testing, HPLC, GC, IC, AA, dissolution (USP App 1 and 2), ICP and wet chemistry.
•Proficient in analyzing data in Empower, Totalchrom, Chemstation, Chromeleon, Shimadzu
•Proficient in current USP, and ICH guidance documents.
•Performed instrument calibration, HPLC, IC and other equipment.
•Conducted IQ/OQ/PQ’s of various instrumentation.

Lead Analyst

Abbott Laboratories

Public Company; 10,001+ employees; ABT; Hospital & Health Care industry

April 2003September 2005 (2 years 6 months)

•Implemented process improvements via the Divisional Change Control System.
•Proficient in Laboratory Information Management System (LIMS) and PeakPro chromatography data analysis software.
•Proficient in writing investigation/deviation/nonconformances.
•Controlled Drug Agent (CDA).
•Initiated/completed product and instrument transfer.
•Initiated/completed instrument IQ/OQ/PQ Validation Master Plan (VMP).
•Assist in the successful completion of validation studies for different productions/stability testing.
•Interact, network, and negotiates with support groups and share information.
•Implemented process improvements via the Divisional Change Control System.
•Proficient in analytical testing, HPLC, GC, TOC, TLC, Dissolution App 1 and App 2, EP testing for
Purified water, and conductivity.

Manufacturing Specialist II

Abbott Laboratory

Public Company; 10,001+ employees; ABT; Hospital & Health Care industry

May 2000May 2003 (3 years 1 month)

•Served as a Project Team Leader for the CRG Business Unit Pilot Group responsible for identifying and eliminating global issues that result in non-conformance. The Teams efforts/successes were recognized as the Divisional Benchmark.
•Implemented process improvements via the Divisional Change Control System.
•Coordinated meetings and product manufacturing schedules.
•Established and organized training of Good Manufacturing Practices for ISO-9000, FDA compliance schedule, including employee training.
•Served as departmental Calibrations Coordinator and maintained the calibration status of departmental instruments.
•As the GMP Coordinator, facilitated a departmental team responsible for identifying and eliminating potential audit risk in preparation for the annual Divisional Laboratory Audits.
•Audited departmental maintenance logs, testing records, and qualification records for completeness.

Public Company; 51-200 employees; KV-A; Pharmaceuticals industry

January 1998January 2000 (2 years 1 month)

Performed and evaluated testing using various analytical techniques.
Evaluated test results for trending purposes.
Maintained proficiency on various analytical techniques.
Proficient in performing techniques requiring medium, small-scale extraction, and chromatography.
Drafted, amended, and verified Standard Operating Procedures for QC Analyst.

Shevonda Spence - Wade's Skills & Expertise

  1. HPLC
  2. GC
  3. IR
  4. GMP
  5. LIMS
  6. Validation
  7. Data Analysis
  8. Calibration
  9. Chromatography
  10. Wet Chemistry
  11. Gas Chromatography
  12. FDA
  13. Sop
  14. UV/Vis
  15. Change Control
  16. Pharmaceutical Industry
  17. GLP
  18. Pharmaceutics
  19. V&V
  20. USP
  21. Empower
  22. Dissolution
  23. Analytical Chemistry
  24. LC-MS
  25. Quality Control
  26. Regulatory Requirements
  27. SOP
  28. Chemstation
  29. Chemistry
  30. Method Development
  31. Laboratory

View All (31) Skills View Fewer Skills

Shevonda Spence - Wade's Education

Walden University

MBA, Project Management

20062008

Activities and Societies: Member American Chemical Society Member Delta Sigma Theta Sorority Inc.

Fisk University

MA, Chemistry

19961998

Activities and Societies: American Chemical Society MARC Program

Tennessee State University

BS, Chemsitry

19921996

Activities and Societies: American Chemical Society Delta Sigma Theta Sorority Inc.

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