What are the responsibilities and job description for the Quality Specialist position at Fusion Life Sciences Technologies LLC?
Position: Senior Quality Specialist (Deviations, CAPA management)
Location: Boston, MA (Onsite)
Duration: Contract | 12 Months
Need local candidates
.
We are seeking an experienced Senior Quality Specialist to support manufacturing and quality operations in a GMP-regulated cell therapy environment. This role will be responsible for owning and managing quality records, investigations, CAPAs, change controls, risk assessments, and compliance initiatives while collaborating cross-functionally to drive operational excellenc
e.
Key Requiremen
ts:• 6 years of pharmaceutical development and manufacturing experie
nce• BS degree in Engineering, Science, or related fi
eld• Strong experience with Deviations, CAPAs, Change Controls, and Risk Assessme
nts• Expertise in root cause investigations and technical writing within GMP environme
nts• Experience with eQMS systems and quality event managem
ent• Ability to support manufacturing operations in Grade B cleanroom environme
nts• Excellent organizational, communication, and collaboration ski