Quality Specialist (in office)

• Location: Boca Raton, Florida
• Type: Direct Hire
• Job #10586

Job Title: Quality Specialist
Job Summary: The Quality Specialist is responsible for ensuring compliance with regulatory requirements and maintaining the quality management system for a FDA registered, GMP compliant skin care manufacturer. The individual in this role will conduct quality audits, review and approve documentation, perform investigations, and implement corrective and preventive actions as needed.
Key Responsibilities:

• Support and conduct internal quality audits to assess compliance with regulatory requirements and the company's quality management system.
• Review and approve documentation such as batch records, change controls, non-conformances, and deviations to ensure accuracy, completeness, and compliance with regulatory requirements and the company's quality management system.
• Perform investigations of quality issues and deviations to identify root cause and implement corrective and preventive actions (CAPA)
• Implement and maintain the company's quality management system to ensure compliance with regulatory requirements and the company's quality policies and procedures.
• Manage the Complaint Process and Investigations
• Support the development and implementation of quality training programs to ensure that all employees are trained in current GMP and quality requirements.
• Assist in the development and maintenance of quality metrics to track the performance of the quality management system.
• Participate in the review and approval of supplier qualification and monitoring programs to ensure compliance with regulatory requirements and the company's quality management system.
• Collaborate with other departments such as production, R&D, and regulatory affairs to ensure that quality standards are met throughout the product life cycle.
• Support the Document Control team in revising SOPs, WI, Forms, and other GMP documentation.

Qualifications:

• Bachelor's degree in a science or engineering field.
• Minimum of 3 years of experience in a quality role in a FDA regulated industry, preferably in a GMP compliant skin care or personal care products manufacturing environment.
• Knowledge, understanding, and application experience of Quality Assurance systems such as complaints, CAPAS, Change Control, Deviations, and Investigations
• Strong knowledge of FDA regulations, GMP, and quality systems.
• Excellent written and verbal communication skills.
• Detail oriented with strong organizational and problem-solving skills.
• Ability to work independently and as part of a team.
• Experience utilizing problem-solving tools for root cause analysis (5Whys, Fishbone, etc).