Quality Assurance Product Support Associate (US Support)

RESPONSIBILITIES:

• Manages the site Customer Complaint Investigation Program, including responsibility for deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries/conclusions.

• Maintains effective communication with Technical Service groups (worldwide locations) regarding this site’s product complaint investigations. Includes review of complaint cases at earliest stage to assess Technical Service performance.

• Labelling Regulatory Compliance, including reviewing product labeling to assure compliance with product claims and supporting the labelling control process.

• Product Recall / Field Action Activities; coordinate activities as required.

• Post Market Surveillance; responsibility for coordinating and implementing this program. May include generation, maintenance and reporting of key metrics for the site.

• Maintains, administers and distributes technical training materials to outside intake groups as well as internal employees.

• Conducts training on performance and usage of key products for external or internal employees as well as customers. Includes specific instructions for new product launches. May require interfacing within key groups related to the DHF process.

• Performs bench testing of any products where Abbott Diagnostics Scarborough is the Regulatory Owner.

• Performs site visits as needed to assess kit performance, including specific activities for Amplicon remediation.

• Participates in the Internal Audit program as a lead auditor and for external vendoraudits as needed.

• Manage the calibration program as needed

• Manage the Freeze/Thaw stability Program as needed.

• Writes, reviews and approves Standard Operating Procedures, guidance documents, and training materials as needed.

• Identifies events that may be subject to vigilance reporting requirements and communicate to Regulatory for evaluation.

BASIC QUALIFICATIONS | EDUCATION:

• Bachelor’s Degree in Chemistry, Biology, Life Sciences, or related technical field or equivalent combination of education and experience.

• Proficient in the use of Database software; Internet software; Spreadsheet software and Word Processing software.

PREFERRED QUALIFICATIONS:

• 5+ years of experience in Quality Assurance role in the medical device industry

• 2+ years of experience in QA/QC role in animal health industry

COMPETENCIES:

• Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements.

• Demonstrated understanding of lab practices. Demonstrated ability to manage complex programs, and multiple priorities in a timely manner.

• Demonstrated ability to analyze data and draw appropriate conclusions.

• Strong communication skills.