Has ownership of and deploys the quality management systems
and test plans as defined by NBTY, Inc. Corporate policies and procedures
Builds and implements factory food safety and quality plans.
Provides guidance, coaching and training to the factory team in the areas
of Quality and Food Safety.
Creates and manages a fully functioning QC laboratory
responsible for microbiological and chemical analysis of raw materials and
bulk dietary supplements following CFR 111 and ISO 17025 requirements.
Provide day to day leadership to Quality Assurance and QC
laboratory department staff. Create procedures to ensure compliance with
current regulations and best practices.
Responsible for the management and oversight of contracted
facility food safety prerequisites, e.g. pest control, water management,
lubricants, boiler additives, laboratory chemical safety, etc.
Provides guidance and assistance, data collection and
interpretation for new product production trials
Functional leader of the HACCP team and deployment of the
HACCP plan to ensure product safety. Must be proficient HACCP principles as
defined in ISO 22000 and the Codex Alimentarius
Understands equipment, commissioning procedures,
pre-operational preparation requirements, process controls and sanitation
requirements for all equipment used to manufacture vitamin supplements at
Develops work instructions provides training in all aspects
of quality, food safety equipment operation and sanitation for associates
at the facility
Tracks and trend quality issues at the plant and provides
data to improve the performance of the quality management system.
Utilizes statistical methods, SPC, DOE, etc., to evaluate
and improve factory process and product performance
Maintains quality management system, associated
documentation and all records required to manage the development,
production and distribution of the products manufactured at these
Conducts root cause analysis
studies with operations to build effective CAPAs, determine disposition of
Work with raw material/component suppliers and Procurement
to effectively communicate quality issues and achieve resolution.
Act as primary liaison to corporate Quality Assurance,
Quality Control and outside Regulatory agencies, i.e. US FDA, Texas State
Department of Agriculture and other agencies as required for the business.
Monitor the performance and competency of Quality staff and
provide development as needed.
Prepare and maintain licenses and permits for the facility
Serve as primary plant liaison for customer/consumer quality
complaint issues. Approve complaint investigations performed by self and
Designs and deploys KPIs as needed to improve factory
performance and reports to KPI information to all levels of the