QA Product Complaint Specialist

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three years in a row.

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

Overview

Reporting to the Director, Product Quality Complaints, the Product Quality Complaint Associate, QA will play a key role in the complaint process. Specific areas of responsibility include Ensure accurate and thorough complaint intake information, replacement need, trouble-shooting with complainant, patient follow-ups, product complaint investigations, tracking and trending of complaint data. The position is based in our Bridgewater, NJ HQ (onsite 3 days a week)

Responsibilities

ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to, the following:  

• Accurately enter commercial, clinical and/or compassionate use complaints into the internal software system/QMS.
• Review each complaint assigned for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events.
• Act as a technical product subject matter expert and trouble shoot complaints with complainants.
• Contact complainants for follow up information, trouble shooting and device returns.
• Perform complaint investigations to determine root cause, identify resolution and respond to the complainants.
• Ensure adverse events reported through the complaint system or at patient follow-up are reported within 24 hours.
• Provide product training and complaint training to internal and external stakeholders.
• 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.
• Investigations associated to complaint trending along with associated CAPA.

Qualifications

• BS or associate degree in engineering, Life Science or related discipline preferred, and a minimum of 1-2 years of relevant Quality Assurance experience.
• Experience with a patient calls/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.

Travel Requirements

Up to 10%

#LI-JT1

Salary Range

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus 
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by 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.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.