QA Product Quality Complaint Specialist
QA Product Quality Complaint Specialist
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1 Vacancy
Job Description
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 patientsfirst 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
Consistently Ranked Sciences Top Employer
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. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences Top Employers survey for four 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 Workcertified 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
Responsibilities
- 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 complaints with complainants.
- Contact complainants for follow up information trouble shooting and device returns.
- Perform complaint investigations to resolve root cause identify resolution and respond to the complainants.
- Ensure adverse events reported through the complaint system or at patient followup 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.
- Handle workload and call volume within predefined 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.
- BS or associate degree in engineering Life Science or related subject area preferred and a minimum of 12 years of relevant Quality Assurance experience.
- Experience with a patient calls/complaint intake in a regulated industry.
- Must be thoroughly knowledgeable on relevant cGMPs and Good Documentation Practices
- Must have excellent communication skills (verbal and written).
- Demonstrate ability to handle 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 Insmeds five 5 values: Collaboration Accountability Passion Respect Integrity.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
Salary Range
Compensation & Benefits
At Insmed were committed to investing in every team members total wellbeing now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members regardless of geographic location:
- Flexible approach to how we work
- Health benefits and timeoff plans
- Competitive compensation package including bonus
- Equity Awards (LongTerm Incentives)
- Employee Stock Purchase Plan (ESPP)
For more information on U.S. benefits click here.
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability protected veteran status or any other characteristic protected by federal state or local law. 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.
Insmed is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities. To request reasonable accommodation to participate in the job application or interview process please contact us by email atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Required Experience:
Unclear Seniority
Employment Type
Unclear
