Remote Quality Assurance Senior Technical Manager

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Fri, Jun 18, 2021

Job Summary

A biotechnology company has an open position for a Remote Quality Assurance Senior Technical Manager.

Core Responsibilities of this position include:

  • Performing independent review and approval of standard operating procedures
  • Reviewing technical content of method submissions to regulatory authorities
  • Managing and approving change control related to method lifecycle

Qualifications Include:

  • High level of proficiency in analytical method validation in a cGMP regulated environment
  • Understanding of FDA, EMA, PMDA and other international regulatory requirements
  • Knowledge of analytical instrumentation, software, and tests performed in the lab
  • Familiarity with Quality Management Systems: GMP document management, and deviation
  • BS in chemistry, or biology or equivalent and +12 years experience in a cGMP regulated manufacturing environment
  • Knowledge of microbiological assays including endotoxin and bioburden

COMPLETE JOB DESCRIPTION

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