Ratry Keointhisone
Boston,MA
Summary
Detail-focused Quality expert known for productivity and efficiency in task completion. Specialize in process optimization, compliance monitoring, and risk management, bringing valuable insights into operational improvements. Excel in communication, problem-solving, and adaptability, ensuring seamless coordination across teams to maintain high standards of quality internal/external control
Overview
9
9
years of professional experience
1
1
Certification
Work History
Quality Auditor
Pro QC International Ltd
McHenry, Illinois
09.2023 - Current
- Conduct audit to ensure organization are in compliance with international and ISO quality standards
- Perform audit to identify any non-conformances, areas for improvement within the organization
- Provided guidance on risk assessment techniques and methods
- Examine processes, procedures, and documentation to ensure compliance with requirements
- Analyze information to determine if there are any gaps in the quality management system
- Plan, schedule, create audit criteria, objectives, provide audit plan and the necessary document
- Conduct interviews with auditees, review documents, and gather evidence to support audit
- Prepare and deliver audit results, document nonconformity, risks, areas for improvement
- Generate and distribute detailed audit report and its recommendation within the target timeline
- Perform audit opening/closing meetings and help with any necessary follow-up work
- Evaluate production processes against company QMS for compliance with quality requirements
- Lead QA auditor team, provide guidance, efficiency and leadership throughout the audit process
- Ensure audit team involves making sure audit reports are accurate, unbiased, and helpful
- Evaluated production processes for efficiency and effectiveness.
Internal Auditor - QA Global
Repligen Corporation
Waltham, MA
07.2022 - 09.2023
- Create and maintain audit schedule and coordinate audit dates throughout organization
- Monitors and supports timely execution of regulatory compliance activities and delivers metrics
- Apply judgment within defined parameters and work reviewed for sound reasoning and accuracy
- Performs evaluation of internal controls, data assessment, communications and risk assessments
- Identify and execute opportunities for continuous improvement and and create audit records
- Document and maintain audit report for compliance and perform trend analyses on audit results
- Ensures all CAPA from assigned audits are effective, verified and closeout in a timely manner
- Collaborate with auditee to address identified issue, provide recom. and facilitate the CA process
- Coordinate audit work, train auditor personnel to ensure projects are efficiently completed
- Analyze metrics to measure effectiveness and make recommendation to improve the IA program
- Drive continuous improvement of core processes to ensure manufacturing quality is maintain while efficiency is optimized
- Ensured that all necessary documents were properly filed according to company policy.
QA Specialist
Pharmaron/EPM Scientific
Medford, MA
09.2021 - 06.2022
- Conduct investigations to assess the root cause of quality incidents and determine effectiveness
- Investigates quality concerns related to manufacturing issues and/or customer product complaints
- Initiate and assist staff in initiating deviations, CAPAs, as appropriate for any noted excursion
- Ensure Corrective Action and its Effectiveness checks are performed by the target due date
- Coordinate of audit and inspection report responses, reduced error and closure of historical gaps
- Train manufacturing staff on quality-related procedures to ensure good documentation practices
- Technical writing and review; tracking action items and identifying trends in recurring events
- Periodically inspect and review critical tools, and review of preventive maintenance data
- Identified, investigated and documented defects in the system.
QA Specialist
Qiagen
Beverly, MA
10.2018 - 03.2019
- Initiate, conduct, write and review Investigations report for NCMRs, Deviations, CAPAs and SCARs
- Create, and implement (SOPs) for processes and document controls by utilizing the company QMS
- Author, revise, review and approve quality Standard OperatingProcedure (SOPs)
- Serve as an expert in the quality review and approval of quality change control records
- Conduct internal and external audits, collect data and analyze for track and trend metrics
- Provides quality oversight for root-cause analysis and impact assessment for investigations
- Prioritize conflicting needs; handle matters expeditiously; and follow through on projects
- Train staff on quality policies, procedures, best practices and ensure up to date training record
- Managed customer complaints, coordinating investigations, and ensuring effective resolutions
QA Tech II
Skyworks Solutions
Woburn, MA
06.2016 - 09.2018
- Review incoming material documentation to ensure documents comply with Quality standard
- Initiate and manage Non-Conforming Material Report (NCMR) and Corrective Action (CAPA)
- Ensure critical material of finished products are in the proper SAP ERP system location
- Ensure all supplier communication and document records are process per company standards
- Ranks and prioritizes suppliers for development and maintain scorecards for all active suppliers
- Perform periodic suppliers audit to verify the compliance practices of regulatory requirements
- Observe process in operation, review quality inspection plan and statistical process control record
- Managed quality control and maintained high level of customer satisfaction.
- Participated in training to maintain technical expertise and proficiency on applicable equipment
- Inspected materials and equipment regularly to check for potential hazards and machine defects
Education
High School Diploma -
Penn Foster Career School
Scranton, PA06-2016
Bachelor of Science - Business Management
Quincy College
Quincy, MASkills
- Commitment towards continual improvement
- Documentation control management
- ISO and Regulatory compliance
- Six sigma methodology
- Principles of GMP and GLP
- Risk assessment
- Audit and inspection process
- Corrective action planning
- Root cause analysis
- Investigation leadership
- Data trend analysis
- Training and coaching
- Supplier Quality evalution management
- Customer complaint management
- Standard operating procedure implementation
- Proficient in microsoft office
Certification
- ISO 9001:2015 Lead Auditor - SAE International
- ISO 19011:2018 AU Management System Auditing - BSI Group
- ISO 13485:2016 Internal Auditor (TPECS) - BSI Group
- MD Medical Device Quality Management System - BSI Group
- Six Sigma Greenbelt - Management and Strategy Institution
- Project Management Lean Process - MSI
Timeline
Quality Auditor
Pro QC International Ltd
09.2023 - Current
Internal Auditor - QA Global
Repligen Corporation
07.2022 - 09.2023
QA Specialist
Pharmaron/EPM Scientific
09.2021 - 06.2022
QA Specialist
Qiagen
10.2018 - 03.2019
QA Tech II
Skyworks Solutions
06.2016 - 09.2018
High School Diploma -
Penn Foster Career School
Bachelor of Science - Business Management
Quincy College