Quality & Compliance Manager Resume Example
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QUALITY & COMPLIANCE MANAGER
Professional Summary
Seasoned Quality Control/Quality Assurance Specialist offering 16 years of experience collecting, analyzing and reporting data. Specializing in quality control inspections to assess and document adherence to conformance specifications while promoting increased efficiency and productivity. Skilled in organizing and prioritizing workflows to complete demanding objectives. Diligent and detail-oriented with dedication to high-quality work.
Accomplishments
- Lean Six Sigma Green Belt Certified (Strategy Management Institute)
- Trained Internal/External Auditor
Skills
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Work History
Quality & Compliance Manager, 01/2014 to 07/2020
Company Name – City, State
Company Name – City, State
- Managed department daily operations of 11 Quality Control Specialists involved with in-progress, and final quality control inspections for the release of product test results in accordance with SOP's, State and Federal regulatory agencies.
- Provided quality guidance to production team members to rectify production issues and maintain high-quality final products.
- Developed, initiated, and led team-oriented work projects for the development and implementation of strategic initiatives, validations, process improvements, and SOPs.
- Reviewed and signed off on process and equipment validation and qualification records during all phases of validation in accordance with FDA guidelines.
- Tracked and trended quality metrics and generated clear and organized data in graphs, charts, tables and written quality reports for Management and Senior Leadership Team.
- Organized and hosted Quality Assurance meetings with Management and Senior Leadership Team to discuss organizational quality metrics and best practices.
- Used Lean Six Sigma (LSS) principles and tools to identify non-value add steps and streamline production operations, and quality review and release processes to increase output while reducing errors and rework.
- Increased Quality Control Team productivity and turn-around time for reporting customer test results by creating and implementing in-process and final review checks during pre and post analytical testing.
- Developed, wrote, and updated SOPs, work instructions, forms, job aids, training checklists and training competencies for the review of batch records and release of product test result processes.
- Developed quality control checklists to coordinate inspections with departmental managers.
- Provided technical support with customer, vendor and regulatory audits to renew contracts and re-certify licenses.
- Conducted internal process and full system audits of the production and support unit areas to ensure compliance with standard operating procedures (SOPs), cGMP, cGDP, and regulatory requirements.
- Opened internal deviation reports to document non-compliant issues, and conduct investigation using root cause analysis and risk assessment to determine immediate actions, and implement long-term corrective actions to correct and prevent non-compliant issues.
- Organized and hosted meetings with internal customers to address and correct non-compliant issues, out of specification issues, and external customer complaints.
- Investigated customer complaints and provided customers with an investigative letter detailing root cause, failure mode, short-term and long-term corrective actions implemented to correct and prevent further issues.
- Opened cases with Company vendors to investigate and address out of specification test results that were non-conforming to quality standards.
- Trained personnel according to training checklists, SOPs, work instructions and job aids, and renewed annual training competences.
- Oversaw Proficiency Testing Programs for all qualitative and quantitative testing methods for Production and Support Services to ensure compliance with CLIA regulations.
- Oversaw Instrument Comparisons, Test Method Comparisons and Site-to-site Comparisons for qualitative and quantitative testing methods for Production and Support Services to ensure compliance with CLIA regulations.
- Assigned blind samples into testing production to determine in-process testing quality.
- Trained personnel on electronic quality management system (EQMS) Master Control for the management of customer complaints, deviations and safety and injury issues.
- Completed monthly work schedules; task schedules; employee payroll for day, evening and night shifts; operating 24 hours, 7 days a week.
- Assisted with preparing and monitoring of the department budget.
- Monitored employee performance and conducted quarterly and annual employee performance reviews.
Quality Supervisor, 11/2005 to 01/2014
Company Name – City, State
Company Name – City, State
- Supervised department daily operations of 18 Batch Release Specialists involved in quality inspection and quality control procedures in accordance with SOPs, State and Federal regulatory agencies.
- Led and facilitated process improvement projects.
- Recognized, resolved and facilitated resolution of non-conforming test results or issues encountered during all phases of laboratory work.
- Identified and rejected product test results, materials and equipment not conforming with specifications.
- Monitored quality performance data by gathering, collating, analyzing data, and producing statistical reports.
- Identified and documented defects and coordinated issue resolution with production team members and functional leads.
- Provided technical support with customer, vendor and regulatory audits to renew contracts and re-certify licenses.
- Conducted internal process and full system audits of the production and support unit areas to ensure compliance with SOPs, cGMP, cGDP, and regulatory requirements.
- Trained and mentored new employees on the overall operations of the quality department, review of batch records, and release of product test results.
- Reviewed and signed off on process and equipment validation and qualification records during all phases of validation in accordance with FDA guidelines.
- Performed review of quality control, daily equipment maintenance, and environmental monitoring of humidity, room temperature and storage unit temperatures of the testing facilities.
- Opened internal deviation reports to document non-compliant issues, and conduct investigation using root cause analysis and risk assessment to determine immediate actions and implement long-term corrective actions to correct and prevent non-compliance issues.
- Developed, wrote, and updated SOPs, work instructions, forms, job aids, training checklists and training competencies for the review of batch records and release of product test result processes.
- Developed quality review checklists to coordinate and aid with departmental reviews and release of product test results.
- Used Lean Six Sigma (LSS) principles and tools to identify non-value add steps and streamline production operations, and quality review and release processes to increase output while reducing errors and rework.
- Completed monthly work schedules; task schedules; employee payroll for day, evening and night shifts; operating 24 hours, 7 days a week.
- Monitored employee performance and conducted quarterly and annual employee performance reviews.
- Assisted with preparing and monitoring of the department budget.
- Maintained a working knowledge of regulatory requirements concerning donor suitability criteria, quality control, equipment maintenance, test reporting, donor deferral and donor reentry protocol.
Senior Quality Specialist, 08/2004 to 11/2005
Company Name – City, State
Company Name – City, State
- Managed Quality Team members in the review of batch records, and final release of product test results in accordance with SOPs and regulatory requirements.
- Trained new employees on the review of batch records, and release of product test results.
- Communicated external client test results in an efficient and expedient manner in accordance with customer requirements.
- Identified and documented non-compliant test results or equipment out of specification during all phases of product testing, and recommended appropriate courses of action to production Leads, Supervisors and Directors.
- Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
- Provided technical support with customer, vendor and regulatory audits to renew contracts and re-certify licenses.
- Assisted with scheduling personnel to meet departmental work requirements.
- Provided technical support in the development, maintenance and updating of departmental, production, and support unit SOPs.
Laboratory Technician, 08/2001 to 08/2004
Company Name – City, State
Company Name – City, State
- Prepared specimens for analysis and verified acceptability of test results within established SOP, cGMP and regulatory guidelines.
- Performed standard laboratory techniques in accordance with SOPs, and recognized and resolved deviations encountered during testing.
- Analyzed quality control data and took appropriate action to maintain accuracy and precision of all testing systems.
- Accurately maintained all records and documentation for all laboratory testing systems.
- Performed computer data entry of test results and component modifications accurately.
- Operated instruments within the scope of training, utilizing established protocols and quality control checks.
- Performed all preventative and corrective maintenance and repairs on equipment as required.
- Trained new employees on the overall use of equipment, preventative maintenance, troubleshooting, quality control and review of test records.
- Maintained confidentiality of all patient information to conform to HIPAA, internal and other regulatory standards.
- Handled specimens according to laboratory protocols to maximize accuracy and precision of results.
- Followed all established guidelines and policies for biological and chemical safety.
Education
Bachelor of Science: Mathematics, 05/2007
The University of Texas At San Antonio - City, State
The University of Texas At San Antonio - City, State
- Majored in Mathematics
Bachelor of Science: Cellular And Molecular Biology, 05/1997
Texas Tech University - City, State
Texas Tech University - City, State
- Majored in Cell & Molecular Biology
- Minored in Chemistry
High School DiplomaJohn Marshall High School - City
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Resume Overview
School Attended
- The University of Texas At San Antonio
- Texas Tech University
- John Marshall High School
Job Titles Held:
- Quality & Compliance Manager
- Quality Supervisor
- Senior Quality Specialist
- Laboratory Technician
Degrees
- Bachelor of Science : Mathematics , 05/2007
Bachelor of Science : Cellular And Molecular Biology , 05/1997
High School Diploma
