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Quality System Specialist

Job ID 

2015-22019

# of Openings 

1

Job Location 

US-NY-BAYPORT

More information about this job:

Overview:

Under the direction of the plant Quality Manager the Quality Systems Specialist/Engineer is responsible for monitoring the compliance of the quality systems, manufacturing processes and associated records for adherence to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) that are in effect assuring the quality of product produced.

 

The QA systems specialist will participate in quality improvement teams to reduce defects and quality issues, and make recommendations to improve the production process based on findings from quality assurance analysis. The Specialist will monitor the procedure to determine if changes significantly improve the process and defect quantities. Collaboration across multiple disciplines is critical for the successful application of quality systems. This role will interface closely with other departments in the facility.

Responsibilities:

  • Assist Quality manager in establishing, implementing and maintaining the quality management system.
  • Manage the Internal Audit Program: schedule, conduct, and report audits; initiate audit findings; distribute and archive audit reports for the required standards and regulations at the site.
  • Report findings to area owners and assist in problem solving for their assigned area.
  • Assist with Quality System training.
  • Work to ensure all QS documentation is accurate and comprehensive. Initiate, edit and/or update policies, procedures, work instructions or other supporting documentation and originate appropriate change notification documentation
  • Facilitate the CAPA process to ensure timely completion of actions.
  • Facilitate, analyze, monitor, trend and report quality notifications including audit findings, corrective actions, preventive actions, customer complaints, and misc. audit nonconformities.
  • Assist with gap analysis as requirements for Quality Management Systems change.
  • Assist in collecting and reporting weekly and monthly Quality Systems reports, e.g. KPI, First Pass Quality, complaints. Etc.
  • Functional member of the HACCP team and deployment of the HACCP plan to ensure product safety. Should be trained in HACCP principles as defined in ISO 22000 and the Codex Alimentarius Commission.
  • Support the development of work instructions/SOPs in all aspects of quality, food safety equipment operation and sanitation for associates at the facility  
    • Utilizes statistical methods, SPC, DOE, etc., to evaluate and improve factory process and product performance.
    • Responsible for continual improvement activities to enhance the quality system
    • Performs other duties as assigned
  • Work collaboratively with      inter-department and cross-functional teams to affect necessary changes in      a timely and productive manner

Experience:

  • Five years related experience and/or training; or equivalent combination of education and work experience
  • Experience with Quality systems, auditing, Root Cause Analysis/CAPA
  • Experience with Food Safety plans/HACCP, GFSI a plus
  • Knowledge of FDA regulations for the GMP of Dietary Supplements and Foods

Education - Certification - Licenses & Registrations:

  • Bachelor's Degree, Science related field preferred
  • HACCP

 

Skills:

  • Ability to prioritize and multi-task
  • Excellent communication and interpersonal skills.
  • Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.).
  • Knowledge in computer software programs (power point presentation, Microsoft office, statistics)

Physical Demands:

Physical ability to lift, stand, climb, bend, etc within a manufacturing environment

Able to work with known allergens especially fish and fish product

About Us:

NBTY is a leading global vertically integrated manufacturer, marketer and distributor of a broad line of high-quality, value-priced nutritional supplements in the United States and throughout the world. Under a number of NBTY and third party brands, the Company offers over 22,000 products, including products marketed by the Company’s Nature's Bounty®, Vitamin World®, Puritan's Pride®, Holland & Barrett®, Rexall®, Sundown®, MET-Rx®, Worldwide Sport Nutrition®, American Health®, GNC (UK)®, DeTuinen®, LeNaturiste™, SISU®, Solgar®, Good 'n' Natural®, Home Health™, Julian Graves, Ester-C® and Natural Wealth brands.

NBTY offers a competitive salary and a comprehensive benefits package, which includes tuition reimbursement, health and dental plans, voluntary short-term and long-term disability, daycare subsidy and 401(k).

NBTY is an equal opportunity employer.

Please contact Human Resources at 631-244-2120 if you should need a reasonable accommodation to submit your information for our on-line job postings.

 

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