Shronda Buckingham
Memphis
Summary
Self-Motivated Quality Manager with a proven record of leadership. 20 plus years of experience in compliance, with a strong multi-functional regulatory and quality assurance background. Successfully developed and managed method validation activities relating to GMP, ISO and FDA requirements, compliance audits, compliance reports, air emission inventories, and construction. Strong communication, analytical and organizational skills with ability to manage multiple assignments concurrently. Proficient in MS Office Software Suite, Minitab, Agile and Oracle. Strong working knowledge of ISO 9001, 14001, 18001, 21 CFR 1270, 1271 and AATB Standards.
Quality management professional with robust experience in driving process improvements and ensuring compliance with industry standards. Skilled in root cause analysis, auditing, and quality control methodologies. Strong focus on team collaboration and achieving results, adaptable to changing needs. Known for reliability, problem-solving abilities, and effective communication.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Quality Manager / Quality Engineer II
Integra Lifesciences
01.2019 - Current
- Review and approve all equipment calibrations and preventative maintenance activities
- Executes and monitors the complaint system
- Participates in multiple certification assessments and regulatory inspections resulting in ISO 13485 certification and FDA approval
- Oversee operational audits and assesses company operations, compliance, and other associated risks
- Participates in multi-disciplinary defect reviews to discern and address root causes
- Develop and implement CAPA plans in response to audit findings, complaints, defects, etc
- Oversee the document control, change control, and training programs at the site
- Built strong rapport with team members, management, and clients to facilitate efficiency and productivity and develop team members
- Facilitate process improvements to successfully decrease errors
- Investigate and resolve customer complaints regarding quality
- Draft or provide guidance on technical documents within manufacturing processes, such as validations and modifications
- Adheres to regulatory guidelines set forth by the FDA, AATB, and OSHA
- Participates in site regulatory and corporate audits
- Creates and presents management review per company and regulation requirements
- Develop and maintain quality metrics and provide performance feedback to management
- Performs assistant and advisory duties for the Director of Quality
Quality Engineer
Neopost, Inc
07.2015 - 12.2019
- Supervised process improvement teams providing Lean tools such as Pareto charts, process flow charts, basic statistics, and control charts
- Worked with VPs' and Leadership to aligned strategic plan with projects and business initiatives for ISO 9001 certification
- Investigated customer complaints, conducted root cause analysis, and developed corrective actions (CAPA)
- Coached and developed internal audit teams
- Created SAP report to determine track supplier quality, quarantined inventory, and communicated these details to the suppliers
- Performed internal audit functions for an ISO 9001:2015 certification
- Aided in developing and facilitating Internal Auditor Training for both new and existing employees
- Participate in the development of Failure Mode and Effects Analysis (FMEA)
Package Engineer
International Paper
06.2010 - 07.2015
- Provided a high level of customer service for onsite testing support
- Collaborated with customers as the company “host” for onsite product testing needs
- Maintained responsive customer communication regarding testing services provided
- Update customer on test status, updates, results explanation and consultation for improvements and recommendations
- Assigned all tests to analyst and technical staff and established deadlines
- Conducted monthly safety meetings to ensure safe work practices
- Managed all package testing laboratory equipment, including instrument calibrations, performance verification, IQ, OQ, PQ
- Conducted training sessions with technical staff, as necessary
Project Engineer
EnSafe, Inc
12.2005 - 06.2010
- Managed a team to complete storm water sampling, soil sampling, and groundwater sampling 3 days ahead of schedule
- Completed operating permit applications for Title V and Minor Source companies
- Developed format and completed emissions inventories, semi-annual and annual compliance reports, and hazardous waste reports
- Managed the construction for well installation, soil removal, soil injection treatments, etc
- Facilitated and schedule training classes for various companies; developed each training class specifically for each facility
- Project Manager for Phase 1 projects and prepared written Phase 1 reports for various clients
- Performed third party audits for clients on documentation, recordkeeping, and various state and federal regulated compliance regulations
- Conducted close-out meetings with respective functional management
- Prepared written reports and evaluated corrective actions
Quality Control Specialist
Eurofins Scientific, Inc
06.2000 - 12.2005
- Prepared written reports and evaluated corrective actions
- Coordinated laboratory operations, analysis of test results, reporting and record keeping
- Conducted in-process audits on critical phases of the studies
- Facilitated method validations with the FDA and private firms
- Managed functional areas to aid in the development, maintenance, and approval of SOP
- Executed, conducted, and reviewed validations and audit reports, some including 21 CFR Part 11
- Performed audits on the data and documentation for the studies conducted (HPLC)
- Conducted audits on internal system, such as equipment maintenance and qualification, sample receipt, training files, policy and procedure issuance and receiving of raw materials
- Conducted close-out meetings with functional management after each audit
- Managed the Corporate Quality Training program
Education
Bachelor of Science - Chemical Engineering
University of Tennessee
Knoxville, TNSkills
- ISO 9001 Compliance
- ISO 14001 Compliance
- ISO 18001 Compliance
- ISO 13485 Compliance
- 21 CFR Part 1271
- 21 CFR 820
- EU-MDR Compliance
- MDSAP Regulatory Knowledge
- AATB Compliance Knowledge
- Process Improvement Initiatives
- Non-Conformance Reporting Expertise
- Change Management Procedures
- Quality Improvement Oversight
- Root Cause Identification
- Comprehensive Internal Auditing
- Quality Assurance Systems
- Compliance Performance Evaluation
- Development Of Corrective Strategies
- Compliance Management
- Document management
- SOP Creation and Implementation
- Continuous improvement
Certification
- 2021, Certified Tissue Bank Specialist (CTBS)
- 2001, Tennessee, No. 20634 Sigma White Belt Certification (International Paper Internal Program)
Accomplishments
- Managed sampling (storm water, soil, and groundwater) project and completed three days ahead of schedule resulting in a $80,000 savings.
- Managed CAR review and reduced past due CARs from 10 to 0 past due.
- Created a modified wastewater process which reduced expenses and increased production.
Timeline
Quality Manager / Quality Engineer II
Integra Lifesciences
01.2019 - Current
Quality Engineer
Neopost, Inc
07.2015 - 12.2019
Package Engineer
International Paper
06.2010 - 07.2015
Project Engineer
EnSafe, Inc
12.2005 - 06.2010
Quality Control Specialist
Eurofins Scientific, Inc
06.2000 - 12.2005
- 2021, Certified Tissue Bank Specialist (CTBS)
- 2001, Tennessee, No. 20634 Sigma White Belt Certification (International Paper Internal Program)
Bachelor of Science - Chemical Engineering
University of Tennessee
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