Quality Assurance Specialist

Alnylam Pharmaceuticals•Cambridge, MA

5d•Onsite

About The Position

The Specialist, Quality Operations QA is an experienced senior level position within Quality Operations. This position will provide on-site operational support from Monday – Friday during the hours of 8 AM – 4 PM at Alnylam’s Norton Manufacturing Facility. The Specialist role is capable of supporting all aspects of cGMP production.

Requirements

A minimum of Bachelor’s degree in sciences or engineering
A minimum of 5-8 years of QA operations experience in a GMP manufacturing facility
Experience with Quality oversight in GMP Operations from Early Stage to Commercial
Excellent understanding of FDA, EMA regulations and ICH guidelines
Excellent organizational, communication, and interpersonal skills
Experience with electronic Quality Management Systems

Responsibilities

QA review and approval of deviations, CAPAs, change controls, PM Plans, Work Orders
QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch records for all unit operations
Performing Area Clearance, Change over operations and OTF support for manufacturing operations
Independently providing forward processing decisions during manufacturing discrepancies
Lead and own disposition activities for the release of API, DS and DSI
SOP generation and ownership for Quality related functions
Ensure adherence to Quality systems for internal manufacturing facilities
Quality oversight of New Product Introductions / Product Re-introductions
Lead and drive site inspection readiness and provide QA support in partner audits and regulatory inspections
Serves as primary QA contact during Major / Critical manufacturing events
Lead complex cross-functional investigations