Quality Management

STEVEN E. CLEMONS

**** ********** **** ************, ** 46236 317-***-**** *******.*.*@*****.***

QUALITY & OPERATIONS MANAGEMENT

Visionary, proactive, innovative, and accomplished management professional with 16+ years of progressive experience and a proven track record of significant successful contributions in quality and operations management. Skilled in project management, process improvement, business analysis/evaluation, new product-development and launch support, supplier management, quality management systems, and process improvement. 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 (GMP’s), customer specifications, and all other applicable requirements.

•Quality Management System

•FDA, ISO & cGMP

•Auditing Management

•Change Management

•Production Operations

•Deviation Management

•Batch Release

•Team Building

•Process Improvement

•Root Cause Analysis

•Performance Management

•Personnel Management

•CAPA

•Risk Analysis

PROFESSIONAL EXPERIENCE

Tridien Medical; 9901 Kincaid Dr. #300, Fishers, IN 46037 06/2015 – 08/2016

Quality Manager

Led Quality Department as part of management team; functioned as Management Representative for site reporting to VP of Quality and Regulatory Compliance. Monitored, measured and continually improved the Quality Management System to ensure a high level of confidence that products and processes satisfied all applicable internal, external, quality, regulatory, and customer requirements.

•Hosted successful regulatory, recertification and customer audits; as well as led successful internal audits

•Oversight and responsibility for: CAPA, Change Control, Training, Material Review Board, Supplier Management, Document Control, Receiving Inspection, Regulatory Compliance, Management Review, Performance Management, Personnel Management and Development, Customer Complaints and Quality Leadership

•Ensured QC support to functional areas/locations within Tridien for routine and assigned technical/improvement projects.

•Provided support for Validation projects, First Article Inspection, PPAP, and new product launch

•Self-motivated to achieve peak performance, surpass top quality standards, streamline operations and meet strategic metrics in timely fashion

Jacobs Engineering @ Roche Diagnostics; 9915 Hague Rd #300, Fishers, IN 46203 12/2014-4/2015

Facilities Engineer/Validation

Accountable for Thermal Mapping Protocol generation (development) and execution for Roche Diagnostic’s K-12 chamber project. Performed all phases of equipment validation (IQ, OQ, PQ), decommissioning, retirement, and Summary Report.

•Developed GMP documentation for execution of chamber validation (Thermal Mapping) protocols

•Collected and reviewed field documentation, test method results and summary documentation while insuring procedural and regulatory compliance; facilitated installation of data collection probe and approved chamber installation

•Worked with Project Manager and Facilities Engineering Team to ensure minimal adverse impact to functional areas, BMS, and project timeline commitments

CES @ Zimmer Industries; 345 E. Main St, Warsaw, IN 46580 9/2014-12/2014

Sr. Quality Engineer

Responsible for gathering relevant, factual information and data in order to solve quality related issues and provide responses to regulatory (FDA) findings. Resolved issues by identifying and applying solutions from acquired technical experience and guided precedents.

•Planned and led projects by identifying and organizing activities into time dependent sequencing with realistic timelines for completion.

•Inspected engineering schematics and product prototypes to find errors and develop corrective actions, implementation and effectiveness verification

•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; 130 N. Vintage Drive, Huntsville, AL 35811 8/2014-9/2014

Manufacturing Leader/Supervisor

Led the manufacture and delivery of quality pharmaceutical products; on time, safely and effectively to meet internal and external customer demands and contractual obligations. Ensured that the highest standards of safety and cGMP's, and manufacturing efficiencies were maintained.

•Ensure manufacturing and product requirements are clearly defined, robust processes are in place, and staff are properly trained to drive compliance with state, federal and local standards and regulations; cGMP, GLP, OSHA, and DEA.

•Support the development of schedules, release of batch records, inventory levels/controls, assignment of work, and running of manufacturing processes to deliver quality product on time.

•Participate in recruitment, selection, promotion, and retention of Value Stream personnel; identify developmental needs

of staff, provide coaching, mentoring, and training.

Eli Lilly; 1555 Harding St, Indianapolis, IN 46221 3/2002-9/2013

Quality Supervisor/Leader

Managed and oversaw the gathering and assimilation of critical quality data to ensure the delivery of the highest quality of products and services in support of internal and external customers. Successfully 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 as well as 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 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 quality system issues and adverse quality trends.

•Implemented Corrective Action plans and performed investigative tasks utilizing established RCA tools.

•Reviewed and approved training documents, validation protocols, technical studies, change controls, and

engineering documents for approval, suitability of use and execution.

Diamond Foods; I1899 Exit 5 Pkwy, Fishers, IN 46038 1/1999-12/2001

Production Manager

Managed all aspects of production operations to include: mixing, filling, sanitation, packaging, shipping/receiving. Led the successful development and management of a high-performance team

Played key role in leading production team that was recognized by Executive Management and customers for meeting or exceeding customer commitments and delivery targets.

MBA Business Management and Leadership

Anderson University, Anderson, IN

BACHELORS Business Administration

Marian University, Indianapolis, IN

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