Associate III, Quality Technical Product Complaints
About The Position
This position is hybrid to our Cambridge MA facility and require frequent on-site presence. 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 Biogen's 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.
Requirements
- Master's Degree or Bachelor's Degree in life sciences or equivalent plus 2+ years of experience in a quality cGMP environment
- Microsoft Office products
- Cross-functional collaboration
- Strong written and verbal communication abilities
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- 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 $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
