Quality Manager

DAVID C. NIACARIS

*** **** *** *****

Pleasant Grove, Utah 84062

Cell Phone: 801-***-****

Phone: 801-***-****

E-mail: ************@*****.***

CAREER SUMMARY

I am an energetic leader with over 10 years supervisory/management experience and the last 6 years working in Quality Assurance for large and small companies. I have held jobs as a Quality Assurance Inspector/Auditor, Quality Assurance Coordinator/Product Tracking Specialist, Quality Assurance Manager and a Quality Manager in addition I am currently working on my Six Sigma Green belt certification. I am skilled in supervision of groups of technical personnel. I am proficient in use of Microsoft Suite, Baan and MAS200 (MRP/ERP Systems). Also, I have a thorough understanding of 21 CFR Parts 210, 211 and ISO 9000/9001. I am known as an honest, hardworking employee. I am also a personable, firm, motivated, and focused leader.

PROFESSIONAL EXPERIENCE

Compax Inc May 2008 to Oct 2008

SLC, Utah

Quality Manager

Primary responsibilities are to assess the overall performance of the Quality department and make corrections or improvements where needed in addition to managing the daily function of the Quality department and its employees. This includes reviewing/updating current SOP’s, Creating needed SOP’s, Leading the Quality department to be more Proactive, Preventative minded, Manage all customer complaints, non conformance (NCR) and Corrective/Preventative actions, Review and sign technical drawings for bottles, caps & tubes. Initiate Six Sigma/SPC systems throughout the plant. Develop/improve inspection processes for both production and Quality departments.

4Life Research Feb 2007 to May 2008

Sandy, Utah

Quality Manager

Primary responsibilities are to establish and implement a Quality department at 4Life Research and manage the operations within the Quality department. This includes creating and writing Standard Operating Procedures (SOP’s) and processes throughout the company, develop a stability program for finished goods, establish inspection standards for raw material/components, in-process material and finished goods. Manage all product releases from both a QA and QC function. Ensure daily compliance to FDA guidelines and regulations. Create and maintain all documentation and forms pertaining to manufacturing, customer complaints, Non-conformance etc. Head up and drive the process to become compliant to the new GMP’s released for the Dietary Supplement industry.

• Implemented an AIB pest control system

• Drafted and completed a Product Recall procedure

• Implemented an AQL inspection process/forms for manufacturing department

• Developed a formal release procedure which shows both physical and systemic status

• Established a formal MDA procedure for the destruction of non-conforming material

• Responsible for SOP training

• Established a cleaning procedure for the Liquid filling department which eliminated microbiological failures

• Manage all products testing including microbiological, chemistry, vitamin analysis, etc.

Aseptic Solutions, USA 2005 to 2006

Corona, California

Quality Assurance Manager

Primary responsibilities are to oversee operations in the Quality Assurance Department. This includes all customer complaints, non conformance reports, in-process checks of finished goods, sampling of incoming raw goods, creating and updating company SOPs; oversaw all environmental testing performed throughout the facility. Worked with Orkin pest control to implement an FDA approved pest control program. Accompanied all Kosher, Organic and FDA auditors during each inspection of the facility.

• Created and implemented HACCP program for each customer that includes training for all employees within the corporation. Additionally, assisted writing and administering a Kosher program for the corporation.

• Implemented the “organic” program for specific customers whereby their products may be labeled as organic.

• Assisted in implementation of PMO program for all milk products.

• Helped to develop the protocol and review technical drawings of the equipment and the plant in order to complete the equipment validation of an Aseptic low-acid rotary head filling system for FDAs LACF program. Worked with chemical manufacturer to develop an acceptable approved EPA sterilant for use in California.

Neways International 2002 to 2005

Salem, Utah

Quality Assurance Coordinator/Product Tracking Specialist

Primary responsibility is to oversee the quality of manufacturing operations in all areas of the company. Work with teams of managers, engineers and line workers to improve existing operations, ensure that the quality system requirements are effectively established and maintained and meet the QSR requirements.

• Implement GMP training for all employees within the corporation.

• Recommend organizational changes as needed to comply with all required standards.

• Generate reports for monthly operations and quarterly management review meetings.

• Responsible for all on hold/quarantine activities such as; inventory management and reporting, disposition determination and cost analysis.

• Responsible for acceptance and release of all materials meeting specifications.

Quality Assurance Inspector/Auditor

Skills include interpreting specifications, reviewing processes and documentation. This position requires expertise in process flow, communication skills and good documentation practices.

• Work with a team of Quality Auditors whose responsibility is to ensure that GMP requirements are met in all areas of the company.

• I have worked in all areas of the company including Receiving Inspection, Manufacturing, Packaging, and Final Audit.

• Coordinate Quality Assurance activities with departments such as Accounting, Research & Development, Shipping and Scheduling.

• Coordinate flow and tracking of all products throughout manufacturing and shipping.

First American Title 1997 to 2002

Salt Lake City, Utah

Field Manager

Primary responsibility is to oversee operations and delivery schedules. This included multiple tasks such as:

• Ensuring timely deliveries of packages to customers via couriers.

• Responsible for route scheduling of employees.

• While working for First American Title, scheduled deliveries for other title companies while handling financial transactions.

• Supervised 6 individuals within the company.

• Liaison between employees and upper management.

• Responsible for trouble shooting any obstacles or route scheduling conflicts that arise on a daily basis while working with the Escrow Officers, County and State Officers.

• Worked with customers to align specifications, improve communication, delivery times, and reducing costs.

• Responsible for training of all new recruits. Responsible for introduction of new recruits to customers.

• Delegate’s tasks to subordinates while training them in better ways to perform job.

EDUCATION AND TRAINING

Pleasant Grove High School, Pleasant Grove, Utah, 1996.

 Advanced Technical Training Center

 Mountainland Applied Training Center

 Quality Training

 Team/Leadership Training

 Chemical/Bio-Hazard Training

 Materials Handling Equipment Training

 Good Manufacturing Practices/Good Documentation Practices Training

 21 CFR Parts 210 and 211

 ISO 9000/9001 Training

 Communications Training

 Technical Writing Training

 Non-Conforming Materials/Disposition Training

 Six Sigma Green Belt certification courses

Reference:

Scott Murrin VP of Quality and R&D, Aseptic Solutions 951-***-****

Jarrod Parry Director of Distribution, 4Life Research 801-***-****

Russell Lepard VP of Operations, Compax Inc. 801-***-****

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