Quality Control Scientist III

Waltham, MA

Posted: 08/01/2019 Industry: Biotech/R&D/Science Job Number: 49343

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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