Quality Specialist

POSITION OBJECTIVE

The Quality Specialist is responsible for managing and improving quality processes through data-driven insights, with a primary focus on the CAPA system. The specialist will lead investigations into quality events, analyze data to identify trends and systemic issues, develop corrective and preventive actions, and report on quality performance to various stakeholders.

Pay

The pay range for this position is expected to be $80k-$93,500k annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Responsibilities

• CAPA Management: Own and manage the CAPA lifecycle, including leading investigations, root cause analysis, and ensuring timely and effective closure of actions.
• Data Analysis: Independently analyze quality data, using statistical methods to identify trends, non-conformities, and opportunities for improvement.
• Reporting: Generate regular and ad-hoc reports for management review, summarizing quality performance, CAPA status, and data analysis findings.
• Process Improvement: Support and lead quality improvement initiatives and projects, promoting the use of tools like Lean and Six Sigma.
• Compliance & Auditing: Ensure all CAPA and quality documentation meet regulatory requirements and internal procedures; support internal and external audits.
• Cross-functional Collaboration: Liaise with other departments, such as manufacturing, engineering, and procurement, to gather information, facilitate investigations, and implement solutions.
• Documentation: Maintain accurate, complete, and audit-ready documentation for all quality events and CAPA activities.

Requirements

• Bachelor's degree in a related field such as Quality Assurance, Engineering, or a science discipline.
• Minimum 3 years of proven experience in a quality assurance or similar role, with specific experience in CAPA management.
• Food industry experience is preferred.
• Strong understanding of data analysis, statistical methods, and quality control methodologies.
• Proficiency with data analysis tools, such as Microsoft Excel.
• Knowledge of relevant quality standards and regulations (e.g., ISO 9001, cGMP, FDA 21 CFR).
• Strong problem-solving, analytical, and communication skills.
• High attention to detail and organizational skills.

Qualifications

Minimum qualifications include a bachelor's degree in a related field such as Quality Assurance, Engineering, or a science discipline, with minimum 3 years of proven experience in a quality assurance or similar role, with specific experience in CAPA management. Food industry experience is preferred. Strong understanding of data analysis, statistical methods, and quality control methodologies. Proficiency with data analysis tools, such as Microsoft Excel. Knowledge of relevant quality standards and regulations (e.g., ISO 9001, cGMP, FDA 21 CFR). Strong problem-solving, analytical, and communication skills. High attention to detail and organizational skills.