Quality Assurance Engineer

Company: The Bountiful Company
Location: Leonia
Posted on: February 21, 2021

Job Description:

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.Qualifications* 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)

Keywords: The Bountiful Company, Tenafly , Quality Assurance Engineer, Engineering , Leonia, New Jersey