About the Role:

• We are looking for three candidates to join our team in a remote position, working in any timezone. The ideal candidate will have at least 5 years of experience with quality management systems.
• Experience with Veeva is a nice-to-have, and candidates with previous experience at will be heavily prioritized.
• The primary responsibility of this role is to support the product complaint system at by triaging product complaints and managing Level I complaint processing and closure in adherence with Complaint policies and procedures, while ensuring compliance with federal regulations.

Responsibilities: 

• Accurately enter complaints into the complaints database in a timely manner 
• Triage complaints to determine complaint code and investigation level 
• Determine if the complaint is associated with an adverse event or medical device
• Document follow-up communication with complainants for additional information or complaint sample returns 
• Re-assign complaints to the appropriate investigation site 
• Close complaints per required timeframes and provide responses to the complainant
• Work with other departments, contract partners, and call centers to resolve discrepancies/deficiencies
• Prioritize complaints and ensure accurate data entry within required timeframes
• Notify appropriate parties upon receipt of complaints
• Support the complaints returns process by determining follow-up required for complaint return samples and documenting communication attempts
• Partner with call centers providing tactical oversight and support
• Provide written communication to senior management and team members Perform other duties as assigned by supervisor

Education Qualification: 

• Doctorate degree OR Master’s degree & 3 years of experience directly related to the job OR Bachelor’s degree & 5 years of experience directly related to the job

Required Skills:

• Project management skills including detailed note-taking, planning, scheduling meetings/workshops, presentation creation, metric analysis, and reporting 
• Excellent written and verbal communication skills in English and Spanish 
• Ability to work in a team-oriented, matrix environment and effectively collaborate with diverse departmental groups -
• Ability to manage a large number of complex projects simultaneously

Preferred Qualifications:

• 5 years of biopharmaceutical experience in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.

Pay Range:
$35 - $39/hr.