Who we seek: A self-motivated individual who can work independently, with minimum supervision, while meeting deadlines, given or self-imposed. This person would be skilled in monitoring, troubleshooting, critical thinking, process control, time management, following through, serving customers, and active listening. Demonstrate understanding of regulatory issues, leadership, attention to detail, orientation to quality, deductive reasoning, problem sensitivity, problem solving, and skilled at decision making. Knowledge of sanitation requirements for quality assurance and food safety criteria (HACCP), food production processing, chemistry, biology, Food and Dietary Supplement cGMP’s. You should also show enthusiasm towards responsibilities and pride in a job well done. 

Position Summary: Evaluates and progresses the timely completion of Customer Complaint Investigations and CAPA Systems activities: Including effectiveness checks, non-conformances, and or deviations, as output from the company Quality System. Additional responsibilities will include MRB Coordinator for the Material Review Board (MRB) committee and ensuring the effective execution of and compliance to the nonconforming material process at Phoenix Formulations.

Essential Functions and Responsibilities to ensure the quality and safety of the product will include, but not be limited to:

• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrent of the nonconformance.
• Ensures all CAPA-related documentation is managed in a complete, clear, concise and controlled manner.
• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with regulatory requirements.
• Includes management of the Customer Complaint/GMP/Investigations and Corrective Action/Preventative Action (CAPA program)
• Primary responsibilities include implementation and maintenance in the following areas:
• Responsible for review of investigations and writing complex investigations.
• Responsible for leading Root Cause Analysis, corrective and preventative action (CAPA). Technical resource for Root Cause Analysis.
• Training on the investigation/CAPA system.
• Responsible for implementing, maintaining, and monitoring the effectiveness of the CAPA Quality System.
• Assembles Customer/Non-Conformances/CAPA trending information for monthly and quarterly management and customer presentations.
• Reports required metrices to all levels of the organization.
• Monitors and analyzes metrics and program trend analysis.
• Ensures all deadlines are met for action items.
• Reviews non-conformances that impact product quality and provides recommendations and corrective actions and effectiveness plans.
• Ensures that investigation/CAPA documentation is compliant with GMP, industry standards requirements.
• Provides follow-up to batch investigations concerning customer complaints.

Minimum Qualifications:

• Mathematical Skills – Accuracy with arithmetic, subtraction, multiplication, division, decimals, percentages, fractions, and algebra.
• Language Skills – Must be able to communicate complex concepts in English, verbally and in writing.
• Computer Skills – Must be able to use Microsoft Office, operate inventory software, time keeping or other business-related software.
• Education – degree in Food Science or a Technical field or have equivalent field experience.
• 1-2 years CAPA work experience in manufacturing plant environment preferred.
• 2-4 years Quality Assurance experience preferred.
• 1-2 years’ experience in regulated manufacturing environment preferred.
• Knowledge of FDA Quality System Regulations preferred.
• Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.
• Good project management skills to deliver an effective service in a timely manner.
• Attention to detail to ensure accuracy of work that forms part of the Quality System Documentation.
• Good written and oral communication skills to ensure effective and report generation and effective communication with all levels of the organization.
• Able to work independently.

Disclaimer: Compensation reflective of candidate’s experience. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. The responsibilities, tasks, and duties of the jobholder might differ from those outlined in this job description and other duties, as assigned, may be part of the job.

We Offer: Medical, Dental, Vision, Life, 401K, Paid Holiday, Paid Vacation, Paid Sick Leave, and more!
** Offers are contingent on successful completion of drug screen and background check**