Shevonda Spence - Wade Email & Phone Number

Colorado, United States

Florida, United States

• Support communications between manufacturer, distributors and competent authorities for all medical device complaint related activities.• Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing.• As required, communicates with physician, physician’s staff and/or patient to obtainpertinent complaint information.• Evaluates and engages appropriate management for critical and/or unusual events.• Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service,Manufacturing) to gather critical input into medical device event reports.• Reviews complaint manufacturing investigation reports and provides comments inaccordance with procedures.• Ensures complaints are processed in a timely manner then reviews and closes complaint files.• Communicates with local and international competent authorities, including generation and/or• submission of medical device event reports as required by applicable local laws and regulations.• Coordinates and prepares responses to competent authority inquiry’s associated with medicaldevice report submission (Serious Injury and/or Device Malfunction).• Participate in preparation for Notified Body audits and or Competent Authority inspections.• When required, support root cause investigations and participates in CAPA (Corrective and• Preventive Action) activities Draft and Compiles case and process metrics.• Supports complaint handling trending activities.

• Manage the exceptions document program including operations Deviation, Laboratory Investigations, and CAPAs.• Certified in Investigation Writing, Corrective Action and Preventative Action.• Managed the Internal Audit program and created audit checklist based on ISO 90001 guidance.• Manage and report KPIs and quarterly metrics for the site.• Participated in the Audit Readiness Program to ensure the site is audit ready.• Manage three Quality Compliance Specialist in Complaints and APRs.• Certified Auditor to perform Internal Audits and Audit Plans.• Responsible for managing customer complaints and annual product reviews (APRs).• Developed and implemented a process to track and trend open Customer Complaints.• Directly responsible for responding to customers product complaints review/approve complaint reports.• Developed visual control boards for all exception documents, customer complaints and APRs.• Responsible creating, reviewing and updating standard operating procedures (SOP) and manufacturing batch records• Develop and Perform Internal audits for the site.• Managed the monthly inspection program for self-auditing program.• Responsible for identifying gaps and clarifying procedural instructions for the internal auditing program. • Initiated recommendations for product trend analysis for corrective actions and preventative actions (CAPA’s).

Huntsville, Alabama Area

• Developed and implemented a process for quality, operations, and laboratory product transfers between manufacturing sites.• Project lead for the realignment of cross-functional quality system and manufacturing training procedures.• Developed and implemented a process to track and trend product returns across multiple sites.• Responsible for initiating and updating Standard Operating Procedures (SOP).• Responsible for identifying gaps and clarifying procedural instructions. • Authored Annual Product Reports; production history, analytical and product lot data, trending and product performance assessment, maintained and monitored the companies’ product list.• Reviewed and drafted non-conformance reports, laboratory investigations, and customer complaints for product impact.• Initiated recommendations for product trend analysis for corrective actions and preventative actions (CAPA’s). • Communicated with cross functional groups within the quality organization any obvious trends that occur during the products annual review period.

Huntsville, Alabama Area

• Provided analytical support for new and existing raw material products oral dosages tablets. • Reviewed supplier Certificate of Analysis to ensure manufacture results complies with company’s specifications, as well as author Certificate of Analysis and reports.• Reviewed and approved laboratory notebooks to ensure proper documentation procedures are followed as per companies’ compliance policies.• Lead and coordinated analytical projects associated the use of HPLC, Dissolution and any other analytical techniques applied to the testing of pharmaceutical drug substances, products, and critical excipients.• Mentored and trained entry-level scientists.• Performed analytical test by HPLC, dissolution (USP App1 and 2), and various methods for wet chemistry analysis.

•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.

•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.

•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.

•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.

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.

Mba, Project Management

Activities and Societies: Member American Chemical Society Member Delta Sigma Theta Sorority Inc.Masters in Business Administration.

Ma, Chemistry

Activities and Societies: American Chemical Society MARC ProgramMaster in Organic Chemistry

Bs, Chemsitry

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