Quality Control Scientist III in Waltham, MA at Integrated Resources, Inc

Date Posted: 7/1/2020

Job Snapshot

Job Description

Manage contract Laboratory Testing for release analysis and stability testing
Handle the samples shipment from CMO to CLO ability
Maintains relationships with CLOs per QTA
Support CLO for lab investigation
Oversee testing programs including: Assay Controls, Reference Standards, Product Release, Stability
Oversees budgeting for CLOs; including contracts and purchase orders

Responsible for external quality testing at CLOs (including in-process, release, and stability); ensures complete documentation for compliance with cGMPs
Maintains relationships with CLOs to ensure Quality Agreements, Statement of Work (SOW), and Manufacturing Service Agreements (MSA) are initiated and updated accordingly
Oversee testing programs including: Assay Controls, Reference Standards, Product Release, Stability
Oversees budgeting for CLOs; including contracts and purchase orders
Support and facilitate deviations and investigations
Support long-term planning of QC lab capabilities and capacity
Responsible for coordinating with AD for the implementation of new technologies into CLO network
Change notification management
Data entry into LIMS
Data analysis for release data
Coordination and drafting of Annual Product Review sections
Coordination of Annual Method Reviews
Coordination/review of compendial methods for compliance
Active participant in the management and direction of the overall QC programs and requirements