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Click here or scroll down to respond to this candidateCandidate's Name
Street Address PHONE NUMBER AVAILABLEEMAIL AVAILABLE LINKEDIN LINK AVAILABLESUMMARYA disciplined worker and accomplished leader with the proven ability to manage multiple assignments efficiently, provide leadership, and motivate others to achieve goals. Recognized for exercising sound judgment under pressure, setting goals, and adopting effective courses of action to consistently provide prompt, reliable, and accurate information to customer inquiries, ensuring customer satisfaction and resolving tough issues.Extensive experience in project management, process improvement, business analysis, evaluations, product development, launch support, supplier management, Quality Systems Management, and process improvement. Makes quality decisions that address or resolve issues based on experience, written procedures, and analysis.Initiated improvements in a wide range of organizations that previously had poor or ineffective quality programs in place. Highly proficient in driving and ensuring all activities comply with ISO Standards, FDA regulations, current Good Manufacturing Practices (GMPs), customer specifications, and other applicable requirements.Develop and deliver a strong overall quality system, strategy, and ultimate plan that results in a fully compliant quality system infrastructure with respect to procedures and processes. Extensive experience driving quality strategy and improvements in a multi-site environment.SKILLSSolution Selling Strategic Planning Operations Planning Cost Savings Manufacturing Practices Problem Solving Key Account Management Cross-Functional Team Leadership Customer Service Leadership Client Relationship Management Team Management Interpersonal Skills Analytical Skills Quality Systems Communications and Marketing Presentations Data Story Telling Operations Process Manufacturing Practices Training/Development Solution Selling Escalation and Reporting Quality AssuranceEXPERIENCEBECTON DICKINSON, Plainfield IN Sr. Quality Assurance Manager 1/2020-PresentManage and maintain an effective local Quality organization, train and develop programs, and subject matter expertise, define and assign responsibilities to the associates, create succession plans, establish annual IIGs and evaluate performance. Certifies and guarantees the development, maintenance, and execution of the DC Quality Management System in compliance with ISO 13485, 21 CFR 820 (QSR), BD Corporate Policies and Procedures, Regional Quality Standards, and other applicable regulations.Work to ensure and maintain a robust, effective Quality Management System that complies with applicable regulations, laws, and BD procedures. Establish and lead local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations. Serve as the Designated Representative as appropriate to guarantee that day-to-day operations meet the state licensing requirements for medical devices and/or the wholesale drug distribution regulations as applicable.Partner with the businesses and provide summary input on key packaging and configuration issues in order to maintain document currency to product and customer requirements. Manage non-conformance process (Quality Notification/QN), collaborate on issues to provide detailed information to source plants, vendors, or carriers to determine root cause and monitor for trends, escalations and partner with sources of root causes to implement effective corrective actions that reduce non-conformances and risk in future shipments.Oversee and monitor the scrap process to ensure compliance with procedure and timelines; and facilitate the escalation process with business units where the disposition of inventory identified for scrapping did not meet established timelines. Escalate the process with the Social Investing group as applicable or where the disposition of inventory identified for donation to charitable organizations is not meeting established timelines.Subject Matter Expert for DC Quality processes, facilitated training, coaching, and direction. Ensured compliance with standardized processes and designated a business unit Quality representative to facilitate and supervise remediation/rework activities with DC personnel.Collaborate with Transportation on carrier-related issues and drive claims to resolution where escalation is needed. Assist Supply Chain and partner with BD businesses on carrier-related issues where root cause analysis and corrective actions are initiated to improve carrier performance.Partner with Operations and Supply Chain Relations on customer-related issues and drove claims to resolution where escalation was needed. Generate monthly and quarterly metric reports for regional leadership review. Attend and participate in Regional DC Quality metric calls. Represent Quality as a member of the local DC leadership team.Travel to support Quality Management and audit functions at other DC facilities and support Customer visits to gain an understanding of Customer issues and determine root causes. Establish and drive corrective actions which improve customer satisfaction. Monitor trends and escalations and partner with sources of root causes to implement corrective actions that reduce non-conformances and risk in future shipments. Oversee and monitor the scrap process to ensure compliance with procedures and timelines.Escalated processes with the business units where the disposition of inventory identified for scrapping is not meeting established timelines and facilitated the escalation process with the Social Investing group as applicable where the disposition of inventory identified for donation to charitable organizations is not meeting established timelines.Subject Matter Expert for DC Quality processes, facilitating training, coaching, and direction. Ensures compliance with standardized processes. Designate a business unit Quality representative to facilitate and supervise remediation/rework activities with DC personnel. Collaborate with Transportation on carrier-related issues and drive claims to resolution where escalation is needed.Assist Supply Chain and partner with BD businesses on carrier-related issues where root cause analysis and corrective actions are initiated to improve carrier performance. Partner with Operations and Supply Chain Relations on customer-related issues and drive claims to resolution where escalation is needed. Generate monthly and quarterly metric reports for regional leadership review. Attend and participate in Regional DC Quality metric calls. Represent Quality as a member of the local DC leadership team.Travel to support Quality Management and audit functions at other DC facilities and support Customer visits to gain an understanding of Customer issues and determine the root cause. Establish and drive corrective actions and improve Customer satisfaction.Aquestive Therapeutics (formerly MonoSol Rx), Portage, IN 11/2017-12/2019Quality Assurance and Quality Systems ManagerQuality Systems Manager-Responsible for all aspects of the companys critical quality systems, including:CAPA Change Control Complaints Internal Audit Batch Record Review Finished Product Release Updates to Quality Manual Supplier Quality Management and SCAR program Ownership of (EDMS) electronic document management system Partner Relationship ManagementQuality Assurance Manager- Managed the MQA Supervisor and quality floor support personnel and oversight of the following quality activities and processes: In-Process product checks Karl Fischer testing Batch Record review Initiation and documentation of Deviations and Events BAS Management Escalation of Product Quality Hold Quality Issues Opening Line Clearance and Closing Line Clearance Containment of Nonconforming Materials and Finished ProductManaged the Event Management System overhaul, developed Quality Leadership Team to provide quality oversight and strategic vision for the quality systems and manufacturing quality teams on site, and developed a cross-functional team strategy for resolving deviations, investigations, and CAPA. Participate in KPI development.Member of Site Leadership Team developed staffing and budgetary plan for QA, managed consultant and contractor workforce, participated in new product launch initiative, Product Development Plan, strategic planning for the manufacturing site, and provided overall leadership to two (2) quality work streams.Review and approval of pharmaceutical/CMC packages defining; manufacturing processes, chemical characteristics, product specifications, and batch consistency.Review and approval of equipment validation.Review and approval of environmental monitoring (EM) data by contract laboratory.Review and approval of Tech Transfer package.Review and approval of Annual Product Quality Review (APQR) to identify trends in product/batch manufacturing.Part of team that led the launch of companys first commercial drug product.INDEPENDENT CONSULTANTS/CONTRACTOR 08/2016- 11/ 2017Integrated Facilities Management and Quality Services Quality ConsultantQuality professional providing management, leadership, and technical expertise to clients in Medical Device, Pharmaceutical, and Food industries.Identify and escalate product and/or process deficiencies and areas for improvement and ensure products and processes meet regulatory, Quality Management Systems, and customer requirements. Strong working knowledge of ISO 13485, 21CFR Parts 11, 210, 211, and 820.HILL-ROM (FORMERLY TRIDIEN MEDICAL), Fishers, IN Quality Control Manager 06/ 2015-08/2016Led Quality Department with responsibility for CAPA, Change Control, Training, Material Review Board, Supplier Management, Document Control, Receiving Inspection, Regulatory compliance, Management review, Customer complaints, Quality Leadership, Performance Management, and DevelopmentMonitored, measured, and continually improved the Quality Management System to ensure an elevated level of confidence that products and processes satisfied all applicable internal, external, quality, regulatory, and customer requirements.Hosted successful regulatory, re-certification, and customer audits and led successful internal audits for ISO 13485 and 21 CFR Parts 11 and 820.Provided support for Validation projects, First Article Inspection, PPAP, and new product development/launch.ROCHE DIAGNOSTICS, Indianapolis, IN 12/2014-04/2015Operations Consultant Facility Engineer/ValidationDeveloped GMP documentation for the execution of incubators, refrigerators, freezers, and warehouse thermal mapping validation protocols. Collected and reviewed field documentation, test method results, and summary documentation while ensuring procedural and regulatory compliance. Facilitated installation of data collection probe and approved chamber installation.Worked with Project Manager and Facilities Engineering team to ensure the minimal adverse impact on the product, sample storage, other functional areas, and Building Management Systems while adhering to project timeline commitments.Facilitated problem-solving and identified critical personnel, gauges, procedures, and materials needed for the completion of CAPAs and response to responsible regulatory bodies.QUALITEST PHARMACEUTICALS, Huntsville, AL 07/2014 09/2014Value Stream Manufacturing Leader/SupervisorLed the manufacture and delivery of quality pharmaceutical products on time, safely, and effectively to meet internal and external customer demands and contractual obligations. Ensured the highest standards of safety and GMPs and manufacturing efficiencies were maintained. Supported the development of schedules, the release of batch records, inventory levels/controls, assignment of work, and running of manufacturing processes to deliver a quality product on time.Participated in recruitment, selection, promotion, and retention of Value Stream personnel. Identify staff development needs, and provide coaching, mentoring, and training.ELI LILLY, Indianapolis, IN Quality Supervisor/Leader 3/2002 09/2013Led and managed the gathering and assimilation of critical quality data to ensure the delivery of the highest quality products and internal customer services in support of internal and external customers. Led the smooth operation of multiple manufacturing facilities, simultaneously utilizing all available production information, forward planning, and correct allocation of personnel resources. Subject Matter Expert in traditional Aseptic Fill/Finishing operations, RABs, Dry Powder Fill/Sterilization, and Biologics.Promoted and drove compliance with quality systems and cGMPs during manufacturing and support processes. Led efforts to reduce process-related and human error deviations; utilized the CAPA system to implement process and procedural changes and training efforts for the Environmental Monitoring (Quality Control) group and manufacturing operations personnel.Part of a cross-functional team that implemented a hybrid paper and electronic system for the collection of microbial and particulate sampling data to significantly reduce documentation-related errors and the resulting deviations. Investigated and performed RCA for deviations generated from procedural, process, and personnel violations. Lead Investigator for product quality issues and adverse quality trends.Implemented Corrective Action plans and performed investigative tasks utilizing established RCA tools. Drafted, reviewed, and approved training documents, validation protocols, technical studies, and change controls.Participated in Factory Acceptance Testing (FAT) for new filling line and cartridge equipment to determine machine capabilities under the intended factory conditions.Part of a team the conduct SAT (Site Acceptance Testing for new manufacturing equipement.Worked closely with Sterility Assurance & Validation to review and execute validation plans for newly designed, redesigned, and retro-fitted manufacturing suites and equipment.Led Environmental Monitoring Quality team efforts to select and qualify new air sampling equipment.Led team of FUME specialists charged with the collection of monitoring/sampling of WFI, clean steam, process air, process nitrogen, and clean steam used in sterile aseptic fill/finishing operations.Responsible for the EM sampling and quality support of multiple manufacturing sites and methodologies to include; powder fill terminally sterilized manufacturing facility, insulin cartridge and pen facility, bulk product operations, oral solid dosing facility, and aseptic fill-finishing of insulin and oncolytic manufacturing.DIAMOND FOODS (formerly Golden Stream Quality Foods) Production Manager (1/1999-12/2001)Managed and oversaw all aspects of 2nd shift operations, including production sanitation, packaging, shipping, receiving, and the successful building and oversight of a high-performance team that overcame diverse cultural and language barriers. Led numerous successful production campaigns, consistently meeting or exceeding production targets. Established performance standards and goals based on site goals and strategies; measured, controlled, made corrective actions, and reported results.Conducted the interviewing, hiring, training, performance, evaluation, and discipline of staff. Gathered, analyzed, and utilized critical data to ensure the delivery of outstanding delivery outcomes of products.Implemented the coverage of resources for troubleshooting and repairing process/packaging equipment problems to maintain desired performance levels.Recommended improvements, which resulted in new and improved equipment and or methods to minimize production costs and improve quality. Reviewed, approved, and enforced Company Standard Operating Procedures (SOPs). Scheduled and monitored training of manufacturing personnel; identified developmental goals of personnel to meet business objectives; made critical decisions affecting employees and all perishable products. Participated in plant inspections, and supported safety, quality, and regulatory inspections.EDUCATIONANDERSON UNIVERSITY, Anderson, INMASTER OF BUSINESS ADMINISTRATION - Business Management and LeadershipMARIAN UNIVERSITY, Bachelor of Business Administration Organizational LeadershipGraduated with Honors: Deans ListMILITARY91F10~Behavioral-Specialist 91B10~ EMT (Medic)COMMUNITY INVOLVEMENTDelta Epsilon Sigma (National Scholastic Honor Society)Wheeler Mission: Ending Hunger and HomelessnessBill Glass Prison Ministries-serving men incarcerated in the Criminal Justice System. |
