Quality Engineer

Scorpion Therapeutics; New York (NY); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive compensation

Career development opportunities

Benefits for you and family

Job summary

Scorpion Therapeutics is seeking a Quality Complaints Investigator to assist with investigations and documentation of quality-related complaints and inquiries from consumers, regulatory agencies, and third-party assessments.

The role coordinates with Consumer Affairs, Pharmacovigilance, and contract manufacturers to ensure timely investigations and proper documentation, while maintaining databases and final reports for stakeholders.

Qualifications

• Bachelor’s degree required.
• Minimum of 2 years of experience in quality/compliance or related field.

Responsibilities

• Coordinate documentation and investigation of quality-related complaints.
• Collaborate with Consumer Affairs and Pharmacovigilance staff to provide product information.
• Prepare final written reports and responses with investigation results.
• Coordinate across Quality & Compliance, Operations, Customer Service, Legal, Regulatory, and manufacturers; notify management of regulatory issues or recalls.
• Maintain and update the complaint/adverse event database.

Skills

Quality investigations

Regulatory awareness

Documentation

Communication

Education

Bachelor's degree

Tools

Database systems

Job description

Description Overview

• Assists with investigations and documentation of quality-related complaints, inquiries, and requests for assistance from consumers, customers, regulatory agencies, and 3rd-party product assessments regarding Perrigo drug and device products per regulatory requirements.

Scope of the Role

• Coordinates documentation and investigation of quality-related complaints and, if associated, adverse drug event reports for company 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; partners with Perrigo and third-party plants to ensure timely and proper technical investigation and complaint documentation.
• Arranges credit and reimbursement for complainants through customer service; prepares final written reports and responses with investigation results for consumers or healthcare professionals.
• Coordinates across Quality & Compliance, Operations, Customer Service, Legal, Regulatory, Value Streams, Sales Operations, and contract manufacturers; notifies management of issues that may require regulatory reporting and/or potential product recall.
• Maintains and updates computer database to track complaints and adverse event reports.

Experience Required

• Bachelor’s degree.
• Minimum of 2 years of experience.

Benefits

• Competitive compensation, benefits for you and your family, and career development opportunities.