Quality Investigator & Compliance Analyst

Perrigo; New York (NY); On-site; USD 75,000 - 110,000; Full time

Job summary

Perrigo in Bronx, NY is seeking a Quality Engineer to support investigations and documentation of quality related complaints for OTC and device products in compliance with regulatory requirements.

You will coordinate documentation with Consumer Affairs and Pharmacovigilance, work with third party plants to ensure timely investigations, maintain the complaint database, and prepare final written reports to consumers or healthcare professionals.

Qualifications

• Bachelor's degree in a related field.
• Minimum of 2 years of experience.

Responsibilities

• Coordinates the documentation and investigation of quality related complaints and if associated, adverse drug event reports concerning Perrigo OTC and device products.
• Works with Consumer Affairs and Pharmacovigilance staff and/or third-party call centers to provide product information in response to consumer inquiries and works with Perrigo and third party plants to insure timely and proper technical investigation and documentation of complaints.
• Arranges credit and reimbursement for complainants through customer service, and prepares final written reports and responses outlining the results of investigations that are sent to consumers or healthcare professionals.
• Interacts with Quality & Compliance, Operations, Customer Service, Legal, Regulatory, Value Streams, Sales Operations, and contract manufacturers, and notifies management of issues that may require regulatory reporting and/or potential product recall.
• Maintains and updates computer database for the tracking of complaints and adverse event reports.

Education

Bachelor's degree

Job description

Perrigo in Bronx, NY is seeking a Quality Engineer to support investigations and documentation of quality related complaints for OTC and device products in compliance with regulatory requirements.

You will coordinate documentation with Consumer Affairs and Pharmacovigilance, work with third party plants to ensure timely investigations, maintain the complaint database, and prepare final written reports to consumers or healthcare professionals.