Highly motivated and accomplished professional with 15+ years’ experience in the Biotech/Pharmaceutical, Medical Device industry as a Document Control, Quality Engineer, Compliance Specialist, Technical Writer, Quality Auditor, Lead Investigator, Deviation and CAPA Management, Manufacturing Supervisor, Change Control, Training Specialist, Manufacturing Technician, Safety Facilitator and GMP Cleaning.

Experience

Independent NC Life Insurance Agent 1/2016 to present

Fuquay-Varina, NC

Specialize in selling Senior Final Expenses (NC license# 17825852)

Merck (Contract) Durham, NC 6/2013 – 6/2015 (Contract Ended)

Quality Specialist I -Deviation and CAPA Management Database Coordinator

Reduced overdue and late Quality Notifications (QNs) and Corrective and Preventive Actions (CAPAs) by 99% using SAP and Midas documentation systems

Reduced number of reportable events by 20% by triaging during Deviation and CAPA Event Initiation meetings

Initiated required QNs and CAPAs within required 1 business day time limit by 100% goal

Performed New Employee (NEO) Deviation and CAPA Management as qualified trainer, meeting monthly training goal time frame

Submitted daily, weekly and bi-weekly QN and CAPA reports to management distribution on time 100% by required time frame using technical writing skills

Assisted Vaccine Bulk Facility (VBF) Team and Vaccine Manufacturing Facility (VMF) Team with triaging QNs using Risk Management and ICH Q9, including Lyophilization, Filling, Packaging, Printing and Formulation

Hospira, Clayton, NC 6/2009 – 11/2013

Manufacturing Specialist II, Quality Lead Investigator, Compliance Specialist, Safety Team Leader

Performed technical writing high level investigations identified by FDA warning letter as required by FDA response determining, root cause, product impact and appropriate CAPAs corrective actions 100% on time using Trackwise and SmartCAPA and other GMP documentation systems using Risk Management and ICH Q9 to determine product impact and effectiveness checks.

Utilized Risk Management and ICH Q9 to determine product impact for Change Control and APRs

Performed investigations related to medical devices such as Evacs, Rotaglide and Rotashield per ISO13485 using Risk Management and ICH Q9 to determine product impact in Formulation, Filling, Inspection, Packaging, Sterilization, Environmental Monitoring, Chemistry, IT, Engineering, Maintenance, Building Services, Technical Services and Validation using tools such as 6MS, 5 Whys, Is/Is Not, KT and Can Do Plan Act

Initiate Corrective Preventive Actions (CAPAs) to address root cause(s) in non-conformance events using and Can Do Plan Act, trending and effectiveness checks

QA Reviewer that provided Subject Matter Expert (SME) input for investigators to achieve 30 day investigation closure date

Developed Deviation and CAPA Management training curriculum to ensure 100% on time training target met .

Train and mentor junior investigators Deviation and CAPA Management process to achieve site wide metric goals

Served as Manufacturing Process Engineer for Small Volume Parenteral (SVP) Packaging Line reducing reportable events by 90% by performing SOP gap analysis, implementing effective CAPAs and performing routine internal audits

Pfizer (formerly Wyeth) Marietta, PA & Sanford, NC 7/1981 – 11/2008

Quality Engineer/Lead Investigator /Compliance Specialist

Performed high level investigations for non-conformance events identified by FDA warning letter, meeting required FDA response timeline 100%, determined, root cause, product impact and appropriate CAPAs corrective actions using Trackwise and SAP. Utilized Risk Management and ICH Q9 to determine product impact and effectiveness checks and Address Change Control and Annual Product Reviews for Formulation, Lyophilization, Filling, Inspection, Packaging, Sterilization, Environmental Monitoring, Chemistry, IT, Engineering, Maintenance, Building Services, Technical Services, and Validation using tools such as 6MS, 5 Whys, Is/Is Not, KT reporting OOS (Out of Specification) and OOT (Out of Tolerance) non-conformance events

Initiate Corrective Preventive Actions (CAPAs) to address root cause(s) in non-conformance events using and Can Do Plan Act, trending and effectiveness checks

Performed investigations related to leechables and extractables

Utilized Risk Management and ICH Q9 to determine deviation product impact and effectiveness checks.

Utilized Risk Management and ICH Q9 to determine product impact for Change Control and APRs

Engineering audit team member that performed internal GMP audits on Critical GMP utilities and Critical GMP equipment, meeting monthly audit schedule 100% on timeline

Performed Technical Services Change Control duties to ensure equipment in validated and qualified state with 100% compliance

Revised SOPs to address FDA audit commitments, meeting FDA response timeline 100% on time

Performed technical writing assignments for SOPs, protocols, training

Wyeth-Sr Supervisor Inspection and Packaging Depts.

Ability to supervise large department of 65+ employees in Inspection, Packaging and Printing Depts

Performed documented GMP training for Inspection, Packaging and Printing Depts; tracking employee training to ensure 100% compliance.

Developed Finishing Section Inspector Qualification Program to address FDA 483 Observation within due FDA Response requirement for semi- automated and manual inspection process

Validation Team Member for Eisai Automated Inspection Machine Factory Acceptance Testing (FAT) in Shizuoko, Japan

Conducted monthly safety inspections, handled hazardous waste materials according to EPA regulations to ensure 100% compliance with Occupational, Safety, Health (OSH) and Environmental Protection Agency (EPA) requirement

Performed site wide GMP training as assigned, such as “Keep the Promise” code of conduct and ethics training to address FDA Consent Decree meeting time line 100%

Used technical writing skills for new SOP development, SOP revisions, training and Change Control

Performed high level investigations for identified by FDA warning letter and Consent Decree meeting required FDA response timeline 100%, determined, root cause, product impact and appropriate CAPAs corrective actions using Trackwise and SAP in Inspection, Packaging, and Printing using tools such as 6MS, 5 Whys, Is/Is Not, KT reporting OOS (Out of Specification) and OOT (Out of Tolerance) non-conformance events

Initiate Corrective Preventive Actions (CAPAs) to address root cause(s) in non-conformance events using and Can Do Plan Act, trending and effectiveness checks

Performed investigations related to leechables and extractables

Utilized Risk Management and ICH Q9 to determine deviation product impact and effectiveness checks.

Utilized Risk Management and ICH Q9 to determine product impact for Change Control and APRs

Wyeth-Asst Supervisor Building Services

Supervised employees responsible for cleaning and disinfecting pharmaceutical facility Class A, B to support manufacturing production with 100% cleaning compliance

Ordered validated cleaning supplies and cleaning equipment working with qualified vendors and sales personnel to achieve lowest cost efficiency

Trained employees using approved and qualified disinfectants and cleaning techniques; tracked employee training to ensure 100% compliance with training curriculum requirements

Developed and revised employee training curriculum to ensure 100% compliance with qualified processes

Education

Penn State – Bachelor’s Degree Business Administration

Experience

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