Associate III, Quality Technical Product Complaints
Job Location:
Cambridge, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
This position is hybrid to our Cambridge MA facility and require frequent on-site presence
About This Role
As a Specialist in Product Complaints you will play a critical role in ensuring the timely and compliant processing of product complaints and associated sample evaluations across Biogens global markets. You will support the complaint intake process coordinate sample receipt and evaluation activities and help drive investigations that support product quality and patient safety. Working closely with cross-functional teams you will analyze complaint data identify trends and contribute to continuous improvement initiatives within the Quality organization. This role serves as a key link between affiliates laboratories and quality stakeholders to ensure consistent complaint handling and regulatory compliance.
What Youll Do
Respond to complaint-related inquiries and support team email management
Process incoming product complaint cases. Coordinates and conducts risk-based case investigations ensuring due diligence global consistency and compliance
Evaluate complaint samples and document results in accordance with GMP requirements.
Support development maintenance and execution of sample investigation methods
Coordinate complaint sample shipments receipt storage and laboratory evaluations
Manage complaint intake activities and sample ship-kit requests
Review and approve customer inputs for accuracy consistency and compliance
Conduct complaint investigations and support root cause analysis activities
Write and revise SOPs concerning the TPC Quality System with minimal guidance
Track and verify corrective and preventive actions (CAPA)
Analyze complaint data and identify trends across products and affiliates
Drive continuous improvement initiatives within complaint management processes
Support laboratory safety training and equipment readiness activities
Who You Are
You are a detail-oriented quality professional who is passionate about product quality and patient safety. You enjoy investigating issues analyzing data collaborating across teams and improving processes in a regulated environment.
Required Skills
Masters Degree or Bachelors Degree in life sciences or equivalent plus 2 years of experience in a qualitycGMP environment
Microsoft Office products
Cross-functional collaboration
Strong written and verbal communication abilities
Preferred Skills
Knowledge of Product Complaint systems/operations and cGMP requirements for biologics oral-dose medical devices drug delivery devices and combination products
Knowledgeable in Product Complaint regulations (e.g. FDA EMA ISO). Medical device and/or combination devices experience
Experience handling deviations and CAPAs
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
IC
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
