Manager Quality Assurance

Juan C. Lopez

**** ****** ***** ***** ** Kennesaw GA 30152

Cell: 404-***-**** - *****.******@*****.***

PROFESSIONAL SUMMARY

Experienced Professional in Manufacturing Operations and Quality Assurance with strong leadership and team building skills.

SKILLS

Project Management, Team Liaison, Budgeting and Finance, Microsoft Word, Excel, Powerpoint or equivalent software, knowledge with Serialization Packaging, Effective verbal and written communication, Bilingual (English and Spanish).

CERTIFICATIONS

Six Sigma (Green Belt)* ERP systems (SAP, JDE, )* Cycle time reduction* KT Decision Analysis and Problem Solving* Payroll Management (Kronos, Paycheck)* Continuous Improvement Process (CIP, KPI)* Statistical Process Capability* Environmental Safety (OSHA, EPA)* Equipment Maintenance (PM systems, Calibration Manager, Blue Mountain)* Quality systems (trackwise, process and equipment investigations, customer compliants, CAPA).

WORK HISTORY

Director of Operations 2010-2017

Mikart, Inc.,

Atlanta, Georgia

Oversee and provide direction to all manufacturing stages (material weighing, blending, solid dosage, liquid manufacturing), packaging operations (line clearance, change over, inprocess testing), materials management (inventory control, release, distribution) facilities maintenance and plant security and safety.

Collaborate with the Director of Quality and Compliance to assure all operations are consistently following FDA, DEA, OSHA, and EPA regulations as well as company procedures and policies. Review customer complaints, vendor complaints, batch discrepancy reports and process validation documents as required.

Interface with FDA auditors and other government officials during plant audits. Assist during potential new business audits.

Plan and budget capital expenditures necessary to maintain or improve operations. Coordinate budget and order placing for capital items with the COO, VP Business Development, Sales and Marketing.

Promote Lean Manufacturing tools, develop efficient ways to use personnel, machinery, and other resources to maximize organizational efficiency and increase productivity.

Director Quality Assurance 2008-2010

Azopharma Inc.

Florida, USA

Assure all process related activities are in compliance with current Food and Drug Administration (FDA) guidelines, regulatory standards, company policies, procedures and quality management systems (QMS).

Lead internal and external GMP compliance audits (as per ISO9000) and assure proper trending and reporting are in effect.

Responsible to audit and approve all standard operating procedures (SOP), manufacturing and packaging instructions/master batch records, protocols and final reports before and after completion.

Responsible to coordinate audits, investigation reports, trending and implementation of Key Process Improvements (KPI’s).

Increase quality impact through product integrity by continuous awareness and knowledge based training as well as identification and problem solving by enhancement of Standard Operating Procedures (SOP’s).

Assure effective communication with all service departments and operations to maintain compliance in Quality, Cost, Safety and Delivery Indicators (FTR, KPI).

Manufacturing Manager 2003-2007

Watson Laboratories

Florida, USA

Train new and existing staff on departmental and general procedures.

Partner with Human Resources in the talent acquisition process. Perform annual reviews and disciplinary actions and training, as needed.

Strategic planning with the Director of Operations and the COO regarding annual financial budget of approximately $6M to assure departmental requirements are accomplished during the budgeted period.

Coordinate production and operating reports to assure operational delivery with 3 direct reports and up to 60 process operators throughout 24/5 schedule.

Monitor and report quality indicators on a weekly basis by continuous awareness and knowledge based training as well as identification and problem solving by enhancement of Standard Operating Procedures, SOP’s.

Assure best practices for set-up and trouble shooting procedures to assure efficient product cycle time attainment and / or reduction and waste reduction.

Promote effective communication with services departments; (Quality Assurance, Engineering, Technical Services, Logistics/Planning and Finance).

EDUCATION

Master in Business Administration (MBA) University of Phoenix, Florida, USA

Bachelors Degree (BA) Inter-American University of Puerto Rico

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