Quality Engineer /Manager

TYRONE ORTIZ

**** ** *** ****** **********, Florida 33324

Cellular Phone: 787-***-****

Home Phone: 954-***-****

E-Mail: ***********@*****.***

Summary

A diversified manufacturing and technical leader with experience in manufacturing environments regulated by the FDA and ISO agencies. Have proven success as a Manufacturing and Quality Assurance Supervisor, in addition to technical responsibilities in the Pharmaceutical and Medical Device industries. Demonstrated success in managing new processes implemented to improve quality, efficiency and productivity. Hands-on experience include: KanBan, Just-In-Time, Kaizen, Lean Manufacturing and Lean Six Sigma methodologies. A creative and analytical problem solver with excellent team-building skills that works well under pressure.

Selected Career Accomplishments

 As a Quality Assurance Technical Supervisor at Noven Pharmaceuticals, was responsible for the leadership of the Material Review Board which worked closely with the management of different areas to review and disposition materials used in manufacturing. In addition, created, reviewed and approved (as the sole quality representative) all QA, Production and Packaging SOP’s.

 As a Technical Supervisor II at Noven Pharmaceuticals, developed and implemented a new training system within the manufacturing area covering the Blending, Coating and Slitting processes.

 As a Manufacturing Supervisor II at Noven Pharmaceuticals participated on the Lean Six Sigma Green Belt project team which improved efficiencies in the Blending, Coating and Slitting processes, resulting in the reduction of setup times in the Blending by 6%, in Coating area by 8%, and the Slitting area by 2%. This included the implementation of several Kaizens which resulted in the reduction of material transportation movements and times within the manufacturing area.

 As a Manufacturing Supervisor at Pall Life Science (Medical Device industry), employed statistical measurements and established goals for manufacturing, including manufacturing line efficiencies and employee productivity measurements. Increased efficiencies from an average of 65% to an average of 93%. This was accomplished by assigning employees by their knowledge and experience skill set and by executing employees cross training plans. Increased the employee productivity from an average of 57% to an average on 96%.

Experience

NOVEN PHARMACEUTICALS, Miami, Florida

Quality Assurance Technical Supervisor I

July 2009 – Present

 Monitored, mentored and supervised the Quality Assurance Inspector team to ensure that quality issues are detected, documented and resolved in a timely and efficient manner.

 Review batch records post completion and approve releases prior to submission to product release.

 Prepare monthly reports for the Quality Council Team which details the number of QA Alerts opened and those dispositioned during the period, including the number of processing failures noted within the period.

 Compile, analyze, generate and publish monthly reports on the Overtime (OT) worked during the month, Absenteeism and Documentation Errors.

 Prepare, review, evaluate, revise and approve SOP’s, document change requests, change controls and related forms for the Manufacturing/Production and Engineering/Maintenance departments.

 Draft and revise departmental SOP’s, forms and documents. Update SOP’s to reflect current practices, policies, FDA regulations and customer demands.

 Oversight responsibility for the Material Review Board (MRB) which was responsible for the disposition of material that was found to be out of specification during incoming inspection and/or during production.

 Investigated the root causes of quality and manufacturing non-conformances, including dispositions and follow up to corrective actions initiated.

 Partnered with Manufacturing/Production Management to resolve non-compliance issues.

 Actively participated on different Continuous Improvements projects utilizing Lean Six Sigma concepts (i.e. QA Sampling Reduction and Helium Leak Test). In addition, participated in different partners’ projects (i.e. Temp Tracer Monitor for EU shipments) and the implementation of the Electronic Batch Records project as a QA member.

 Assisted Manufacturing Engineering, Research and Development, and Technical Services departments in completing projects designed to improve, develop and validate current and future processes. Coordinate with planning the time to perform the Annual Swabs per products and processes.

 Internal Auditor Volunteer - audited proceduralized systems throughout the company to ensure that these were in compliance with internal procedures and external regulations.

 Determined staffing requirements and assigned these to the manufacturing areas as deemed necessary.

 Responsible for the direct supervision of 11 direct reports, including two lead inspectors.

NOVEN PHARMACEUTICALS, Miami, Florida

Controlled Substance Manufacturing Supervisor II / Technical Supervisor II

November 2006 – July 2009

 Accountable for the Blending, Coating and Slitting processes. Ensured that manufacturing batch records were completed according to cGMP’s, SOP and QOP requirements.

 Reviewed batch records after completion and initiated manufacturing releases to the product release process.

 Generated daily reports related to the activities to the manufacturing operations during the manufacturing shift.

 Prepared monthly reports on the overtime, setup time vs standard times, absenteeism, downtime and batch record errors. Evaluated the performance and productivity of the employees.

 Investigated the root causes of quality and manufacturing non conformances, gave dispositions and followed up the corrective actions.

 Updated Manufacturing SOP’s for Blending, Coating and Slitting processes.

 Developed training system within the manufacturing area covering the Blending, Coating and Slitting processes. Trained employees to new and updated SOPs.

 Directly supervised seven direct reports, including one lead manufacturing operator.

 Developed and implemented several continuous improvement projects.

 Internal Auditor Volunteer - audited proceduralized systems throughout the company to ensure that these were in compliance with internal procedures and external regulations.

 As a team member of a Lean Six Sigma team, worked on the improvement of the efficiencies of Blending, Coating and Slitting processes which resulted in the improvement of the e Overall Equipment Efficiency (OEE) metric from 40% to 85%.

Pall Life Science, Fajardo, Puerto Rico

December 2004 – November 2006

Production Supervisor

 Responsible for all manufacturing operations within a cleanroom environment for the second and third shifts.

 Created PVR’s (Process Verification Report) when non-conformances were identified.

 Investigated, analyzed and responded to Customer Occurrence Report (COR), performing parametric analysis and verifying lot files.

 Ensured that employees completed batch records according to cGMP’s, SOP and QOP requirements.

 Worked in conjunction with manufacturing engineering to reduce waste in the manufacturing area. Scrap rates were reduced by a 20% during the period.

 Worked with the production planning department to meet customer demands as measured by on-time delivery, inventory, production throughput and number of backorders.

 Increased the manufacturing lines efficiencies from an average of 65 % to an average of 93%, and increased FTE productivity from an average of 57% to an average on 96%.

 Responsible for the direct supervision of fifty (50) employees.

Pall Life Science, Fajardo, Puerto Rico

Facilities Engineer

April 2003 – December 2004

 Accountable for site-wide projects including construction and maintenance projects.

 Prepared departmental budgets and cost-effective analysis for the projects.

 Verified that all the equipment and the facilities were working in excellent condition and maintained the records the preventive maintenance of the equipment.

 Managed the Deionization Water System and developed the departmental SOP for the cleaning, utilization and sanitization of the Water System and other equipment.

 Obtained quotes and supervised projects developed at the manufacturing plant by contractors. Used MS Project Management track all phases of the projects. Achieved a total cost savings of $325K on utilities expenses.

 Responsible for the direct supervision of fourteen (14) employees.

Education

 Master in Engineering Management, Polytechnic University of Puerto Rico

 Bachelor of Science in Industrial Engineering, Polytechnic University of Puerto Rico

Skills

 Lean Six Sigma Green Belt Certified

 Project Management – Planning and Scheduling

 Validation Requirements and Methodology, Facilities Management

 Microsoft (Word, Excel, Power Point, Outlook and Access). In addition Lotus Notes, JD Edwards, TrackWise and Documentum programs.

 Statgraphics and Minitab Statistics software Root Cause Analysis and Statistical Process Control

 OSHA’S 40-Hours Hazardous Waste Operations and Emergency Response Certified

 CPR / First Aid Certified

Membership

AMERICAN SOCIETY FOR QUALITY (ASQ)

Contact this candidate