QC Supervisor

This position is responsible for providing direction, creating processes and quality systems that align with our customers? requirements as well as directing Quality activities in compliance with cGMP, FDA, and other regulatory requirements.

Key Responsibilities:

• Develops and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
• May serve as liaison between the company and the various governmental agencies.
• Assists with the development of control systems for new processes and products.
• Establishes policy and strategy during new product start-ups.
• Verifies process validation studies are conducted correctly and creates validation documentation for any OTC products.
• Primary contact for all formula updates and revised raw material specifications received from customers.
• Works directly with operations to ensure that inspections, statistical process control analyses and audits are conducted as specified to enforce requirements and meet specifications. Responsible for administrating inspection procedures and standards.
• Establishes and ensures that inspections are conducted prior to the processing of raw materials, ingredients, product, and packaging specifications.
• Investigates customer complaints and provides direction for the resolution of quality related issues.
• Meets department financial objectives through the development and management of annual budget.
• Identifies department goals and delivers results tied to departmental and plant goals
• Manages and develops direct reports by through goal development, addressing performance and identifying training.
• Ensures timely completion of all required departmental and plant safety training. Ensures a safe working environment.
• Oversees the Retention and Stability Sample program.
• Provides method and instrumentation support to the laboratory.