BestSweet Inc. is a family-owned and operated Mooresville, NC, manufacturer with more than 70 years of heritage in the confections industry. BestSweet aims to be the most dynamic company in its market segment through world-class manufacturing and marketing of confectionery, cough drop and nutraceutical products. BestSweet produces top-quality, innovative goods that appeal to all tastes, which is demonstrated through its global customer base. Some of BestSweet’s best-known products include: Baskin-Robbins Candy, Lites Sugar Free Hard Candies and its BestHealth brands.

BestSweet is currently searching for a R&D Quality Engineer to work in our Innovation Group located in Mooresville, North Carolina.

Position Summary: Under the general supervision of the VP of Innovation and indirect guidance from the VP of Regulatory, the quality engineer is responsible for ensuring documented compliance of all applicable regulatory standards via generation, review and/or disposition of all Innovation Quality documentation.

Essential Duties and Responsibilities:

·         Works within the Innovation department and with other functional groups in support of new product development projects/activities.  Plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products by performing the following duties. 

·         Communicates regulatory requirements for new development projects.  Assists Regulatory Affairs in developing submissions for new products as necessary.

·         Participate in Quality System programs to assure compliance to Quality System Regulations. 

·         Provide Quality consulting to Core Teams as needed.  Assist in conducting internal audits of Innovation procedures to ensure compliance.  Support external auditors in Innovation compliance reviews.  Assist in HACCP programs as needed.

·         Effectively manage project deliverables, negotiate with internal regulatory personnel and external clients/customers as needed.

·         Maintains a working knowledge of government and industry quality assurance codes and standards.

·         Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.

·         Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.

·         Provides quality design guidance to product development teams for various new product development initiatives.

·         Participates in design reviews and pre-validation assessment to ensure the safe and sound start-up of new processes.

·         Participates in Quality System programs to assure compliance to Quality System Regulations.

·         Assist with creating and executing product stability tests, including protocols, data interpretation, and final compliance reviews.

·         Responsible for review and approval of manufacturing batch records, product specifications and process specifications.

·         Applies statistical tools (Statistical Process Control, Six Sigma, and DOE) methods for analyzing data to evaluate the current process and process changes.

·         Reviews all Innovation purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.

·         Creates and maintains Innovation SOP's (Standard Operating Procedures).  Write, review and/or approved Innovation GMP documentation, including but not limited to process and product validation protocols, reports, and equipment qualifications as necessary.

·         Prepares reports to communicate involvement and results of quality assurance activities.

·         Prepares and presents technical and program information to team members and management.

·         Provides direction to technical and administrative workers engaged in quality assurance activities related to Innovation projects.

·         Establish and develop effective quality control and associated risk management plans for new and existing products.

·         Assist in Company Corrective and Preventative Actions (CAPA) as appropriate.

·         Acts as R&D liaison between core/cross functional group

 QUALIFICATIONS:

·         Bachelor's degree (B. A.) from four-year college or university in a technical or scientific field; or equivalent combination of education and experience

·         Must have a minimum of 5 years solid experience in Quality Assurance, Regulatory, Quality R&D function within the pharmaceutical industry

·         Excellent communication skills both oral and written

·         Intermediate level skills working in Project Management software and MS Office

·         Self Starter, high degree of personal integrity, must be able to multi-task, team player, able to working a cross-functional organization, quality and safety conscious

·         Must be detail oriented and comfortable working in a fast-paced environment

·         Must be able to use: SPC, Six Sigma, and DOE tools

BestSweet offers a competitive salary package in addition to a comprehensive benefits package including a 401(k) with company match.

Qualified candidates may apply on-line by sending a resume.  No recruiters please.

BestSweet is an Equal Opportunity Employer