Facility Quality Supervisor (Day Shift)

POSITION OVERVIEW

Under the direction of the Manager Facility Quality, the Facility Quality Supervisor is responsible for monitoring the compliance of the quality systems, manufacturing processes and associated records for adherence to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) that are in effect assuring the quality of product produced.

In addition to monitoring the daily quality activities on the production floor, the Facility Quality Supervisor will participate in quality improvement team to reduce defect and quality issues, and make recommendations to improve the production process.

KEY RESPONSIBILITIES

• Maintains compliance with quality systems, manufacturing processes and associated records for adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs).
• Monitors daily quality activities of the Microbiology personnel.
• Helps resolve microbiology issues.
• Supports the Quality team members to ensure that products and processes comply with the relevant requirements of the quality management system.
• Maintains compliance with processes and associated records to company standard operating procedure requirements and works with operations and R&D if necessary.
• Works collaboratively with inter-department and cross-functional teams to affect necessary changes in a timely and productive manner.
• Keeps accurate attendance records; file proper reports (accident, probation, etc.).
• Supervises, counsels, and coaches associates on a regular basis.
• Assists in training the factory team in the areas of microbiology, hygiene and sanitation.
• Supports trains quality personnel.
• Understands equipment, commissioning procedures, pre-operational preparation requirements, process controls and sanitation requirements.
• Identifies issues affecting efficiencies and assists in developing solutions.
• Supports on-time closure of assigned deviations, change controls, document control and CAPA.
• Conducts root cause analysis and implements corrective actions for process related concerns.
• Responsible for continual improvement activities to enhance the quality system.
• Performs other duties as assigned.

EXPERIENCE AND EDUCATION REQUIREMENTS

• Bachelor’s Degree in Science or other related field preferred.
• Five years related experience and/or training; or equivalent combination of education and work experience.
• Knowledge of FDA regulations for the GMP of Dietary Supplements and Foods.
• Experience with Food Safety plans/HACCP, GFSI a plus.

SKILLS

• Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.).
• Knowledge in computer software programs, (PowerPoint presentations, Microsoft Office, statistics, Veeva, PLM, AS400, SAP).
• Excellent communication and interpersonal skills.
• Able to work with known allergens especially fish and shellfish product.