GMP Quality Assurance Associate Job at Globalchannelmanagement, Indianapolis, IN

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  • Globalchannelmanagement
  • Indianapolis, IN

Job Description

GMP Quality Assurance Associate needs 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.

GMP Quality Assurance Associate requires:

  • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences
  • Testing experience with Small Molecule
  • Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
  • Knowledge of pharmaceutical manufacturing operations.
  • Demonstrated coaching and mentoring skills.
  • Experience in root cause analysis.
  • Demonstrated application of statistical skills.
  • Demonstrated strong written and verbal communications skills.
  • Strong attention to detail.
  • Proficiency with computer system applications.
  • Excellent interpersonal skills and networking skills.
  • Ability to organize and prioritize multiple tasks.
  • Ability to influence diverse groups and manage relationships.
  • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.

GMP Quality Assurance Associate duties:

  • Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
  • Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
  • Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.
  • Participate in projects to improve productivity.

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