Senior QC Analyst - Onsite, Method Transfers & Compliance

Alnylam Pharmaceuticals

Norton (MA)

On-site

USD 89,000 - 120,000

Full time

13 days ago
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Benefits offered by this job

Medical, dental, vision coverage
Life and disability insurance
401(k) match
Paid time off
Wellness days

Job summary

The QCO Analyst III at Alnylam Pharmaceuticals in Norton, MA will execute routine and non-routine analytical assays for raw materials, in-process samples, product release, and stability studies, while contributing to data trending, investigations, and laboratory operations.

You will participate in method transfers, method qualification/validation, verification, and implementation, ensure data reviews, and support inspections and regulatory readiness in a GMP environment.

Qualifications

  • B.S. in chemistry, biology, or biochemistry, or related field.
  • 6–10 years in GMP QC function or equivalent.
  • Experience with method transfer/analytical method implementation.
  • Technical writing skills, investigations preferred.
  • Strong data analysis with attention to detail.
  • Excellent communication and teamwork.

Responsibilities

  • Perform routine and non-routine analytical assays to support materials and product testing.
  • Maintain up-to-date training records and adhere to testing schedules.
  • Assist in equipment and inventory maintenance and reagent prep.
  • Review data timely and qualify as data reviewer.
  • Contribute to method transfers and validation activities.
  • Support regulatory readiness and onsite inspections.

Skills

Data analysis
Investigations & CAPA
LabWare LIMS
Excel
Communication & teamwork
Technical writing

Education

B.S. in chemistry, biology, or biochemistry, or related scientific field

Tools

LabWare LIMS
Excel
PowerPoint
Word

Job description

The QCO Analyst III at Alnylam Pharmaceuticals in Norton, MA will execute routine and non-routine analytical assays for raw materials, in-process samples, product release, and stability studies, while contributing to data trending, investigations, and laboratory operations.

You will participate in method transfers, method qualification/validation, verification, and implementation, ensure data reviews, and support inspections and regulatory readiness in a GMP environment.

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