QUALITY ANALYST

The Quality Analyst is expected to be a self-motivated, focused, and flexible individual with a positive approach to quality and risk mitigation. This individual must be able to actively navigate complex quality systems and adhere to regulatory, customer, and company policies at all times. Communication with all departments within the organization as well as customers in a professional and timely manner is paramount. The Quality Analyst will report to the Quality Manager and be expected to perform tasks listed in this job description or as assigned.

Responsibilities

• Review Certificates of Analysis and release raw materials
• Interface with 3^rd party laboratories for sampling, testing, and reporting needs
• Generate finished product Certificates of Analysis and distribute to customers
• Initiate and document complaint investigations and product issues
• Conduct new product assessment and verify finished product formulations
• Assist with the development, writing and/or implementation of corrective and/or preventive actions (CAPA) resulting from internal and external audits
• Support development and implementation of processes and procedures meant to improve quality and risk mitigation strategies throughout the organization
• Ensure ongoing compliance with quality and industry regulatory requirements
• Review and update procedures, work instructions, and forms as per the document control policy
• Organize and/or ensure that knowledge and competency assessment records are completed on time
• Document results of and ensure completion of environmental monitoring program
• Participate in HACCP review, Food Food/Product Defense Assessments, and Vulnerability Assessments
• Compile and analyze statistical quality control data
• Assist in internal and external audits
• Complete customer questionnaires and answer inquiries regarding the quality system
• Lead new hire and refresher training to increase departmental efficiencies and continuous improvement
• Support Quality department as required

Desired Skills and Experience

• Experience within a Quality Management System required
• Experience with pharmaceutical and/or food manufacturing preferred
• Experience in food safety is a plus
• Knowledge and experience in cGMPs and relevant Safety Regulations (e.g., OSHA)
• Experience with Microsoft Outlook and Excel required
• Attention to detail and ability to prioritize project and workload
• Must be able to identify issues and communicate with all departments within the organization to get them resolved.
• Strong analytical and problem-solving skills.
• Bachelor’s degree in Biology, Chemistry, or a related field is preferred
• Travel between New Jersey and Pennsylvania facilities is required

Requirements

• Education: Bachelor’s degree in Biology, Chemistry or a related field is preferred
• Experience: 4 to 6 years of experience in a Quality Assurance/Quality Control setting. Experience in a cGMP environment