Product Recall Specialist

Job Description

The Recall Coordinator is responsible for processing product recalls in accordance with FDA regulations and Lincare procedures and policies, ensuring the safety of our customers when notified of a product issue that requires customers to stop use, Distribution Centers to stop shipments, and/or affected product requires isolation and containment. The employee analyzes data to determine the impact of the recalled product on the business and its customers and creates documents with instructions for communication to all locations and customers, ensuring the necessary actions are taken based on the notification letter received from the initiating supplier of the Recall. Instructions may include inspection and identification of product, quarantine, supplier returns, disposal of products, how the customer is to respond if they have the product in their possession, and/or have used the affected product. In addition to these primary responsibilities, the Recall Coordinator supports the continual development and maintenance of the company's records and programs in support of its related business functions.

• Supports Center operations with periodic FDA and internal audits
  
  • Provides information needed for status of recall, quarantines, and product returns to the recalling manufacturer
  • Responds to inquiries made by management to resolve customer needs or concerns, including recall instructions, product listing information, and product returns and credit information
  • Collaborates with internal stakeholders, including Procurement, Category Management, and Customer Service teams as required
• Provides information needed to support the recovery of costs for the administration of the recall
  
  • Provides backup documentation in support of manufacturer cost inquiries and works with the National Healthcare Service Department Manager in support of the cost recovery effort as required

Qualifications

Minimum Requirements

• Entry level professional
• Desired backgrounds may include healthcare, Medicare, pharmaceuticals, biologics manufacturing, or clinical research

Critical Skills

• Intermediate proficiency with MS Office [specifically Word and Excel (Pivots, VLOOKUPS, Macros)]

Additional Knowledge and Skills

• Familiarity with FDA Title 21 CFR Part 7 related to Recalls
  
  • 21 CFR part 806 and established guidelines is helpful
• Knowledge of quality processes is helpful
• Ability to conduct analysis of data using software such as MS Access or Excel, organize information, produce reports based on provided instruction
• Must have affective communication skills
• Familiar with computer business software applications, including word processing (MS Word), spreadsheets (MS Excel), databases (MS Access), Internet/Intranet, and electronic mail, printers, copiers, fax machine and calculation aids for data entry, enquiry, and reporting
• Excellent writing skills
• Excellent telephone etiquette
• High energy level with a sense of urgency, comfortable performing multifaceted projects in conjunction with day-to-day activities
• Good reasoning abilities and sound judgment
• Resourceful, well organized, highly dependable, efficient, and meticulous
• History of stablishing credibility, decisive
• Good people skills
• Must speak effectively before groups of employees, including management

PHYSICAL DEMANDS:

The employee must occasionally lift and/or move up to ten pounds.