Compliance Specialist

Fremont, CA 94555

Posted: 07/09/2019 Industry: Biotech/R&D/Science Job Number: 49232

  • Individual contributor role responsible to manage investigations, own change control records and lead projects in support of manufacturing. 
  • This person will support in the planning, monitoring, reporting of deviations, CAPAs, Change Controls and improvement projects.    
  • Manages small to medium / simple to moderately complex deviation events using root cause analysis techniques.  
  • Utilizes clear writing strategies to ensure content is clear, concise and complete.

  • Possesses knowledge in the area of manufacturing Biopharmaceuticals. 
  • Has experience in managing simple to moderate projects, deviation investigations and CAPAs.  Possesses knowledge of cGMP systems and of regulatory requirements from different regional jurisdictions. 
  • Has experience leading and facilitating meetings, has experience writing technically - SOPs, Protocols, Deviation Reports, etc. 
  • Must be able to multi-task - will work on several records simultaneously.  
  • Must have a composure around management- demonstrated confidence speaking to Sr. Management.

  • A bachelor’ s degree in science or engineering related field is beneficial, but not required.  
  • Associates degree with 5 years of experience or High School Diploma with 6 years’ experience in cGMP Biopharmaceutical manufacturing, with positions of progressive responsibility are required.

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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