The Quality Assurance Engineer provides overall quality support for manufacturing and quality departments to improve overall Solid-Dosage product quality. This is an excellent opportunity for an individual with strong engineering, quality and operations background.
Responsibilities include, but are not limited to:
- Participate in quality improvement initiatives to reduce defects and quality issues, and make recommendations to improve the production process based on findings from quality analysis.
- Collaboration across multiple disciplines, which is critical for the successful implementation of the corrective actions.
- Interface closely with other cross-functional groups such as our Manufacturing, Engineering, R&D and Quality.
- Sets and monitors SPC data to ensure delivery of consistent quality. Utilize basic statistical tools to analyze for trends or issues.
- Develops and analyzes statistical data and specifications to establish product and process capabilities (Cp/Cpk).
- Identify, develop, and implement process controls to meet customer/specification requirements.
- Develops/authors verification and validation protocols (i.e. Validation Plans, IQ/OQ/PQ protocols, validation summary reports).
- Assists and coordinates equipment, cleaning and process validations.
- Participate in and support the maintenance of the Quality Management System and Maintain Quality Department business metrics.
- Lead and / or support thorough investigations of quality issues (CAPA’s, Non-Conformances, Audit Observations, etc.) ensuring effective corrective and / or preventive actions occur.
- Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects.
- Performs assessments of any given quality system to determine the effectiveness and dependability of such system.
- Ensures all quality specifications are met for any given product or procedure and suggests methods to bring equipment and work procedures into compliance with quality control standards.
- Direct support of project activities and all other associated Quality functions.
- Assist in investigations, which includes interactions with vendors or Supplier Development and Procurement Management for issues associated with raw materials and components.
- 5+ years of experience in the food, nutraceutical, pharmaceutical and or supplement industry preferred.
- Ideal candidate has experience with solid-dose techniques (including Mixing, Blending, Tableting, Encapsulating and Coating).
- Knowledge of regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business, preferred.
- Bachelor’s in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field preferred or other closely related discipline with extensive significant experience can be considered in lieu of a Bachelor’s degree.
- ASQ CQE or CQM preferred
- Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
- Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.).
- Knowledge of regulatory and GXP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred
- Strong analytical skills; able to use data, communicate key trends, develop and execute continuous improvement plans.
- Six Sigma Green Belt preferred
- Ability to work with cross-functional groups to implement improvements
- Strong organizational skills; ability to manage multiple tasks and work well under pressure
- Demonstrated ability to work effectively with individuals at all levels of the organization.
- Demonstrated ability to use influencing skills to accomplish goals and objectives
- Capable of lifting 40 lbs.
- Work environment may be exposed to powders, chemicals and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish)
The Nature's Bounty Co. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
The Nature's Bounty Co. offers a competitive salary and a comprehensive benefits package, which includes health and dental plans, voluntary short-term and long-term disability, life insurance, flexible spending accounts, 401(k), tuition reimbursement, generous associate discounts and more!
Please contact Human Resources at 631-200-2120 if you should need a reasonable accommodation to submit your information for our online job postings.