Associate scientist

Contract: Irvine, California, US

Salary: $40.00 Per Hour

Job Code: 321850

End Date: 2022-10-27

Job Status: Expired

This Job is no longer accepting applications

Responsibilities: 

  • Perform data and document review to ensure data integrity and compliance of laboratory reports including but not limited to Microbiology and Analytical data, method validation, stability and technical reports. 
  • Draft technical documents including but not limited to OOS and non-conformance quarterly trend reports, equipment Out of Tolerance investigations, Standard Operating Procedures and Work Instructions. 
  • Oversee critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules. Initiate equipment change control and assist with coordination of set up and qualification activities for new assets. Assist with OOT investigations in the Asset Management System. 

Skills: 

  • Experienced in GMP regulated drug development environment. 
  • Knowledgeable of typical data, data types and documentation that are produced in CMC during clinical development of pharmaceutical and biological drugs (e.g. manufacturing and QC of clinical trial material, stability testing, test method transfer). 
  • Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents.  
  • Familiarity with CDC compliance requirements for Select Agent Toxin program preferred. 

Experience: 

  • Must possess a BS in molecular biology, biochemistry, or related field with at least five years of relevant experience. Knowledge of GMP, ISO, and FDA regulations a plus.  
  • Familiar with process and test method validations.  
  • Excellent communication skills.  
  • Ability to perform under pressure to meet project deadlines. 
Job Requirement
  • Documentation
  • Data Review
  • GMP
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Harish Yadav
  • harish.yadav@collabera.com
This Job is no longer accepting applications
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