Product Complaints Specialist
Redbock - an NES Fircroft company, Boston, MA, United States
Contract Role: Product Complaints Specialist (6 months+ potential for extension)
The contractor will support end‑to‑end product complaint management in accordance with internal procedures and applicable regulatory requirements.
Key Responsibilities
Document, triage, and process product complaints
in alignment with internal SOPs and regulatory guidelines.
Perform initial complaint assessments , ensuring accurate categorization, priority determination, and identification of potential quality or safety risks.
Coordinate sample retrieval, handling, and evaluation , ensuring proper chain‑of‑custody and timely movement through the investigation process.
Collaborate cross‑functionally
with Quality Assurance, Manufacturing, Technical Operations, and other stakeholders to investigate product defects and determine root causes.
Ensure complete, accurate, and timely complaint records , including data entry, investigation summaries, and closure documentation.
Support complaint trending and sample tracking activities , contributing to product quality monitoring and continuous improvement.
Must Have
3+ years of pharmaceutical end‑to‑end complaints management experience
Experience with commercialized products
Availability to be onsite (NE Boston) 4 days per week (WFH Fridays)
Bachelors or Advanced Degree
Nice to Have
Experience with cardiovascular, autoimmune, and inflammatory conditions
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The contractor will support end‑to‑end product complaint management in accordance with internal procedures and applicable regulatory requirements.
Key Responsibilities
Document, triage, and process product complaints
in alignment with internal SOPs and regulatory guidelines.
Perform initial complaint assessments , ensuring accurate categorization, priority determination, and identification of potential quality or safety risks.
Coordinate sample retrieval, handling, and evaluation , ensuring proper chain‑of‑custody and timely movement through the investigation process.
Collaborate cross‑functionally
with Quality Assurance, Manufacturing, Technical Operations, and other stakeholders to investigate product defects and determine root causes.
Ensure complete, accurate, and timely complaint records , including data entry, investigation summaries, and closure documentation.
Support complaint trending and sample tracking activities , contributing to product quality monitoring and continuous improvement.
Must Have
3+ years of pharmaceutical end‑to‑end complaints management experience
Experience with commercialized products
Availability to be onsite (NE Boston) 4 days per week (WFH Fridays)
Bachelors or Advanced Degree
Nice to Have
Experience with cardiovascular, autoimmune, and inflammatory conditions
#J-18808-Ljbffr