Quality Assurance Specialist

3 days ago

Nashville, Tennessee, United States August Bioservices Full time
Job Title: Supplier Quality Specialist

August Bioservices is a leading Contract Development Manufacturing Organization (CDMO) headquartered in Nashville, TN. We are seeking a highly skilled Supplier Quality Specialist to join our team.

Job Summary:

The Supplier Quality Specialist will be responsible for supporting the development, management, and execution of the supplier quality program to ensure compliance with regulatory authorities, cGMP, and customer requirements.

Key Responsibilities:
  • Execute and coordinate the Supplier Quality Assurance Program, including planning and executing supplier audits, maintaining approved vendor lists, and continuously assessing supplier status.
  • Prepare quality agreements and support execution, including coordination of negotiations with suppliers, customers, and partners.
  • Lead the supplier change notification process and ensure notifications are assessed for impact based on risk.
  • Identify and mitigate risk at the supplier level or escalate to management.
  • Support quality systems documentation control within MasterControl and physical documentation control initiatives.
  • Support client audits and communicate clearly with cross-functional teams and customers.
  • Ensure GxP compliance of all August products and services and customer expectations are met or exceeded.
Requirements:
  • Bachelor's degree in science or other related discipline.
  • A minimum of 3 years supplier quality management experience in the pharmaceutical industry.
  • Experience performing quality system audits of suppliers.
  • Ability to write reports effectively and concisely.
  • Experience interacting with customers, suppliers, and senior management.
  • Knowledge of cGMPs and other global regulations and guidelines related to the manufacture of APIs and drug products.
  • Experience with electronic Quality Management Systems is desired.
  • Experience with Pharmaceutical Development and Clinical Trials is desired.
About August Bioservices:

We are a privately-owned, high-growth, and high-impact CDMO that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow.

We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred, and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward.

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