Quality Assurance Consultant in South San Francisco, CA at Apex Life Sciences

Date Posted: 3/27/2018

Job Snapshot

Job Description


Seeking two (2) Quality Assurance Consultants to perform some tactical work and review a variety of documents, protocols, and reports. We will consider varying levels of experience.  

Responsibilities

  • Documents review and batch disposition of API and drug product used in Phase 1-3 clinical studies.
  • Review and approve manufacturing records, change controls, investigations and analytical data
  • Review and approve Contract Manufacturing Organization investigations including impact assessments
  • Review and approve test methods and method validations
  • Review manufacturing validation protocol and reports
  • Review and approve Computer Systems Validation(CSV) protocols and reports for QA

Responsibilities:

  • BS, MS or PhD degree in a science related field 
  • 5+ years of experience in QA 
  • Experience in small molecule manufacturing and contract manufacturing 
  • Knowledge of ICH Q7, Q8, Q9, Q10 
  • Knowledge of Computer Systems Validation in line with 21 CFR part 11 
  • Knowledge of GAMP 5 validation 
  • Knowledge of ICH Q1, Q2 and Q6 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.