Quality Assurance Specialist

1 week ago


Indianapolis, Indiana, United States Global Channel Management Inc. Full time
About the Job

Clinical Quality Assurance Representative at Global Channel Management Inc.

We are seeking a highly skilled Clinical Quality Assurance Representative to join our team. The ideal candidate will have a strong background in GMP pharmaceuticals and 2+ years of experience in a similar role.

Key Responsibilities:

  • Perform incoming sample inspection for batch release and ensure product packaging and labeling compliance.
  • Provide oversight for sample management to ensure compliance for the handling of Special Security Substances (SSS) and controlled substances.
  • Obtain authorization to handle Controlled Substances (CS).
  • Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations that apply to sample management.
  • Serve as the QA Data Steward for reserve sample lots created in SAP.

Requirements:

  • Strong knowledge of cGMPs, Quality Systems, and FDA Regulations.
  • Bachelor's degree in a science-related field and/or relevant experience in a pharmaceutical GMP environment.
  • Ability to work across functional areas with people of all levels of the organization.
  • Strong oral and written communication skills.
  • Demonstrated interpersonal and networking skills.
  • Ability to gather, edit, organize, and summarize information from multiple sources.
  • Must exhibit attention to detail.
  • Ability to work under time pressure with proven demonstration of good judgment in making decisions under minimum supervision.
  • Excellent teamwork and interpersonal skills.


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