Complaint Associate, Quality Assurance
- 10 Finderne Ave, Bridgewater, NJ 08807, USA
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
Reporting to the Associate Director, Quality Assurance - GMP, the QA Complaint Associate, will play a key role in the complaint process and related customer interactions. This role has a critical interface with the commercial Patient Support Program and will work directly with the team on a daily basis to manage product complaints, device inquiries and support. Specific areas of responsibility include: Complaint intake/entry into Veeva, ensuring accurate and thorough complaint intake information, Preliminary assessment of all complaints within 24 hours for regulatory escalation and replacement need, trouble-shooting with complainant, maintaining work instructions, patient follow-ups as needed, etc.
- In conjunction with Patient Support Program Team, accurately enter complaints into the internal software system.
- Assess new complaints within 24 hours of receipt for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events.
- Act as technical product subject matter expert and trouble shoot complaints with customers
- Maintain complaint process work instructions
- Contact costumers for complaint follow up information, trouble shooting, and device returns.
- Provide product training and complaint training to commercial stake holders.
- Ensure Adverse Events reported through the complaint system or at patient follow up are reported within 24 hours.
- Assist with complaint closures, complaint review board, and other related QA activities as necessary.
- Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
- Manage workload and call volume within pre-defined KPIs and SLAs
- Recognizes and identifies opportunities for improvement around product complaints and device support processes; shares best practices with the Patient Support & Quality teams
- BS Degree in Engineering, Life Science or related discipline and a minimum of 1-2 years of relevant Quality Assurance experience. Additional related work experience may be substituted for educational preparation.
- Experience with a call center/complaint intake in a regulated industry
- Must be thoroughly knowledgeable on relevant cGMP's and Good Documentation Practices
- Must have excellent communication skills (verbal and written).
- Demonstrate ability to manage projects and variable workloads.
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Must successfully exhibit Insmed’s five (5) values: Collaboration, Accountability, Passion, Respect, Integrity.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.