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Candidate's Name
105 Mimosa Court; Athens, AL 35613PHONE NUMBER AVAILABLEEMAIL AVAILABLESUMMARYThirty years of experience in Quality and Manufacturing combined, in facilities compliant with federal and state regulations. Proficient in managing and performing QA inspections, internal and external audits, laboratory testing procedures, and polymer manufacturing. Demonstrated the ability to lead, work independently, and collaboratively with other departments.Supervised and mentored Quality Assurance Technicians and Inspectors.Presented original polymer research five consecutive years at technical meetings.Trained personnel in Good Manufacturing Practices topics and TrackWise software.WORK EXPERIENCEMay 2020 to Jan 2024Quality Assurance Lead; TriRx Pharmaceutical Services; Huntsville, ALResponsibilities: Authoring monthly quality metrics reports; performing in-process checks of manufacturing and packaging processes; verifying cleaning of equipment; writing of customer complaints; sampling and release testing of packaging components.Aug 2018 to May 2020Project Supervisor; Stratosphere Quality; Tennessee RegionResponsibilites included: Ensured teams were operating according to standards and requirements; scheduled and managed teams of 5 to 20 Quality Inspectors of automobile parts; sorted parts to assess the process and to provide necessary training and direction to team members; met with the customer to maintain and manage customer relationships; wrote work instructions and change control documents; showed flexibility to work all three shifts.Jan 2018 to Jun 2018Validation Specialist; Oxford Pharmaceuticals; Birmingham, ALResponsibilities included: Authored validation protocols and reports; executed test protocols, including resolution of deviations; prepared summary, deficiency, and discrepancy reports.Aug 2016 to Aug 2017Principal Quality Engineer; PAR Pharmaceuticals; Huntsville, ALResponsibilities included: Reviewing of Protocols and Reports for Equipment Qualification and Process Validation; providing subject matter expertise to support change controls, SOPs, and investigations to ensure compliance; participating in Engineering Change Request (ECR) Review Board; leading the team of 12 individuals to ensure closure of completed ECRs; supporting liquids and tablets manufacturing, and the distribution center.Nov 2013 to Jul 2016Quality Assurance Supervisor; PAR Pharmaceuticals Tablets Plant; Huntsville, ALResponsibilities included: Writing protocols and Non-Conformance Reports (NCRs); writing and reviewing customer complaint investigations; executing quality assessments; performing QA cleaning checks and in-process checks; supervising and scheduling of QA Technicians; training of over 60 personnel in TrackWise software; coordinating with warehouse personnel for rejecting nonconforming materials.Mar 2011 to Oct 2013QA Compliance Specialist II; Qualitest/PAR Pharmaceuticals; Huntsville, ALResponsibilities included: Reviewing and closing deviations; answering direct questions from an FDA inspector; scribing during an FDA inspection; presenting cGMP and software training sessions; authoring, tracking, and closing customer complaints; leading a team of 7 individuals that reduced the number of customer complaints from 51 to 1 in three months; reporting daily and weekly quality metrics.PUBLICATIONS (latest at top)Middleton, J.Candidate's Name , C.T.; Kines, P.P.; Rogers, A.R.; Strong, J.T. Degradation of VariousSterilized Lactide, Glycolide, and Caprolactone Polymers. Presented at the 21st Annual Southern Biomedical Engineering Conference, Bethesda, MD.EriCandidate's Name , J.C. AnIn Vitro Degradation Study Comparing Poly (DL-lactide-co-glycolide) with Acid End Groups and Ester End Groups. Presented at the 20th Annual Southern Biomedical Engineering Conference, Birmingham, AL.Williams, Candidate's Name , J.C. Long-Term Stability of Lactide andGlycolide Polymers. Presented at the Sixth World Biomaterials Congress; 17th, 18th, and 19th Annual Southern Biomedical Engineering Conferences.EDUCATIONUniversity of Alabama at Birmingham; B.S. in Chemistry with Mathematics minorJohn C. Calhoun State Community College; Decatur, Alabama; A.A.S. in Chemistry |
