The Associate Quality Assurance Engineer (QAE) provides guidance, expertise and services to ensure process and product quality of reagent products in Food & Feed Safety and Next Generation Sequencing. The QAE supports the enhancement and implementation of ISO 9001 quality system to ensure overall compliance and customer satisfaction. The QAE performs product quality inspection and batch release; monitors material, process and production controls; works with manufacturing to ensure procedures meet requirements; works with purchasing and manufacturing to resolve incoming material quality issues; processes non-conforming material and deviation records.
Essential duties and position responsibilities:
- Together with Management drives an organizational culture of quality
- Supports CAPA program, NCM and Deviation administration
- Assists in product quality investigations
- Uses software to generate metrics for quality trending
- Performs data entry into quality system management software QCBD
- Engages with document revision/approval process
- Assists with data compilation for investigation or reports
- Assists with complaint handling and resolving customer requests
- Manages supplier qualification, evaluations, and metrics
- Maintains records organizational systems, including basic indexing and filing
- Other duties as assigned by manager
- BS degree in life science with 2 years’ experience in quality assurance or quality control role
- Previous experience in an ISO 9001, 13485 or GxP compliant manufacturing environment
- Previous experience with quality management system software for quality data tracking and document change management (e.g. TrackWise, MasterControl, Agile, QCBD, etc.)
- Proficient in using Microsoft Office suite including Excel, Word, PowerPoint
- Strong written and verbal communication skills
- Positive, people-oriented, energetic attitude; able to work in a fast-paced environment
- Self-motivated, highly organized, and able to prioritize and manage multiple tasks
- Previous auditing experience to ISO 9001:2015 or ISO 13485:2016
- Complaint handling experience
- Specific product and application knowledge in food and feed safety or next generation sequencing products
- Application of concepts in continual improvement, Lean, 5S, Six Sigma, DOE, statistical analysis (Minitab, JMP software)
- Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
- The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
- Onward Search is a drug-free workplace.
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