Quality Control Scientist III

Waltham, MA

Posted: 07/01/2019 Industry: Biotech/R&D/Science Job Number: 49199

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

Skills:
  • Responsible for external quality testing at CLO’ s (including in-process, release, and stability); ensures complete documentation for compliance with cGMPs
  • Maintains relationships with CLO’ s 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 CLO’ s; 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

Education:           
  • BS/MS in a scientific discipline with a minimum of 10 years experience in a GMP regulated industry (e.g. pharmaceutical or biotechnology). Experience managing contract laboratory organizations (CLO’ s) preferred.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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