Quality System Specialist
information about this job:
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.
- Assist Quality manager in
establishing, implementing and maintaining the quality management
- 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
- 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.
- 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
- Responsible for continual
improvement activities to enhance the quality system
- Performs other duties as
- Work collaboratively with
inter-department and cross-functional teams to
affect necessary changes in a timely and
- Five years related experience
and/or training; or equivalent combination of education and work
- 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
Certification - Licenses & Registrations:
- Bachelor's Degree, Science
related field preferred
- Ability to prioritize and
- Excellent communication and
- 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)
ability to lift, stand, climb, bend, etc within a
to work with known allergens especially fish and fish product
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
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