Quality Analyst (I)

Job Description

The Quality Analyst is responsible for managing the document review group by creating, managing, and distributing quality analysis reports and making recommendations to improve the production process based on findings from quality assurance analysis of the quality management systems.

Additional responsibilities include, but are not limited to:

• Monitor the compliance of processes and associated records to company standard operating procedure requirements
• Report findings to Quality Manager and assist in problem solving
• Develop CAPA plans and lead continuous improvement initiatives
• Manage on-time closure of assigned deviations and CAPA’s
• Document results of new procedures after implementation to show quality improvements
• Write and implement test procedures to obtain the defect information needed for analysis and report findings from test and inspection data to management
• Analyze quality inspection data to identify all types of quality problems and perform root cause analysis
• Analyze plant controllable consumer complaint data to identify all types of quality problems and perform root cause analysis
• Initiate investigations and support deviation documentation process utilizing the company’s electronic database system
• Assist in collecting and reporting weekly and monthly Quality reports, e.g., First Pass Quality, Complaints, NCR, Deviations, and others as assigned
• Participate in employee quality improvement teams to reduce defects and quality issues
• Monitor the improvement procedure to determine if changes significantly improve the process and the defect quantities
• Maintain documents for Audits.
• Create new processes or modify and improve current processes by setting up clear and definite quality systems and SOPs
• Collaborate across multiple disciplines and interface closely with our Operations, Distribution, Technical Services, R&D and Procurement teams
• Participate in multi-function team activities, support and maintain Quality Systems and perform other assignments as directed by Manager

Qualifications

• 2+ years of experience in the food, pharmaceutical and or dietary supplement industry preferred
• Knowledge of regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business
• Bachelor’s Degree 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, Visio)
• Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE, 8D, etc.)
• AS400 Knowledge desirable
• Knowledge of regulatory and GXP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred
• SQF practitioner / FSSC/ BRC / ISO experience preferred
• Strong communication skills both verbal and written across all levels of management
• Solid attention to detail to maintain audit records and audit reports
• Strong interpersonal and collaboration skills