Spec Product Recall Sr

Under limited supervision, the Senior Recall Specialist leads and oversees complex product recall activities, serving as a subject matter expert for both sub-recall and company-initiated recall notifications in accordance with internal procedures and applicable FDA regulations.

Responsibilities

• Lead, execute, and coordinate sub-recall notifications and company-initiated recall activities in accordance with internal procedures and FDA regulations.
• Serve as the primary subject-matter expert for recall execution, providing guidance to internal stakeholders on regulatory requirements, timelines, and documentation expectations.
• Independently manage and respond to FDA effectiveness checks, regulatory inquiries, and follow-up requests related to recall activities.
• Serve as the recall liaison between the company and the FDA district office, facilitating clear, professional, and timely communications.
• Organize and oversee designated returned product areas to ensure timely, accurate, and compliant processing of recalled product.
• Issue and oversee return labels, RGAs, credits, and replacement products to support effective recall resolution.
• Review and respond to internal and external recall-related communications within established timelines.
• Maintain complete, accurate, and audit-ready records for all sub-recall and company-initiated recall activities.
• Collaborate with vendors to reconcile recalled product returns and resolve discrepancies.
• Provide direction to Quality Control personnel to identify, segregate, and secure affected recalled product to prevent release for sale.
• Prepare and present periodic recall status reports, metrics, and summaries for Quality leadership and other stakeholders.
• Conduct periodic and quarterly internal audits of recall activities to ensure compliance with internal procedures and regulatory requirements.
• Identify, recommend, and implement process improvements to strengthen recall effectiveness, efficiency, and inspection readiness.
• Train, mentor, and provide ongoing guidance to Recall Specialists and new recall personnel.
• Work proactively and collaboratively with Quality Assurance, Quality Engineering, Operations, Sales, and other cross-functional teams to support recall execution and continuous improvement.

Requirements

• High School Diploma or GED.
• 3–5 years of progressive experience in regulated administrative, quality, or operational roles, including direct involvement with product recalls, regulatory documentation, customer communication, and regulated process execution.
• Demonstrated experience interacting with regulatory agencies and supporting or leading recall activities is required.

Skills

• Strong knowledge of FDA recall requirements and regulated quality processes, with the ability to independently manage complex recall activities.
• Clear, professional written and verbal communication skills for interaction with FDA representatives, customers, vendors, and internal teams.
• Excellent organizational and attention to detail skills to maintain accurate recall documentation, returned product tracking, and audit readiness.
• Ability to interpret and consistently apply regulations and internal procedures while exercising sound judgment with minimal supervision.
• Demonstrated ability to train, mentor, and provide functional guidance to recall personnel.
• Advanced proficiency in Microsoft Outlook, Word, and Excel, with the ability to quickly learn recall and quality systems.
• Ability to manage multiple time-sensitive priorities in a fast-paced, regulated environment.

Preferred Qualifications

• Associate or Bachelor’s degree in a related discipline.

Pay

$23.25 - $33.75 hourly. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp for employees working less than 30 hours per week.