Job Description

QA/QC Director – Fairfield, NJ

Summary:

The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.

Responsibilities

• To ensure that the production facility is operating at a high operational and compliance standard.
• Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
• Monitor each department’s operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company’s clients.
• Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
• Ensure that deadlines are met
• Train and develop colleagues
• Assist employees to solve problems, using quality management techniques
• Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
• Help to promote the implementation of quality systems throughout the company
• Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
• Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
• Other duties assigned by Management

Education:

• Bachelor’s degree in a scientific discipline with a minimum of 10 years’ experience in quality management

Experience Requirements:

• Experienced with liquid manufacturing and packaging of Rx products.
• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with ANDA and NDA submissions
• Experience with validations of processes, cleaning, analytical methods, facilities and equipment
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes and GDP.

Computer Skills:

• Microsoft Word
• Microsoft Excel
• Empower 3

Other Requirements:

• Has significant technical knowledge of quality management principles.
• In depth knowledge of all laboratory equipment, practices, and procedures
• Ability to think logically and independently
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English

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