Quality Assurance Specialist

2 days ago


Indianapolis, Indiana, United States Beacon Hill Full time
Job Title: Supplier Quality Specialist

Beacon Hill is seeking a highly skilled Supplier Quality Specialist to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the site's Supplier Quality program meets applicable GMP regulations.

Key Responsibilities:
  • Maintain the certified supplier list and ensure site supplier assessments are current and up-to-date based on quality risk.
  • Ensure operational compliance with US and international regulatory agencies and guidelines.
  • Serve as site auditor for suppliers and ensure adherence to supplier schedule.
  • Author and own supplier change control (notifications) process.
  • Submit SCAR deviations to suppliers for defects found.
  • Provide support for FDA or other regulatory agencies for on-site audits.
  • Serve as site Quality SME on MSD.
Requirements:
  • Bachelor of Science in Biology, Chemistry, or related field required.
  • 3 or more years of relevant experience required.
  • Experience investigating exceptions and out-of-specifications preferred.
  • Must be able to resolve problems, handle conflict, and make effective decisions under pressure.
  • Action-oriented and drives for results; ability to multitask projects.
  • Must be proficient in use of Microsoft suite office products; good computer skills, including utilizing personal computers and data entry programs.
  • Good hands-on, analytical, and problem-solving and decision-making skills.
  • Excellent writing and verbal communications skills.
  • Ability to work independently and with others to accomplish goals and priorities.
  • High level of energy and regular, consistent attendance.
  • Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment.


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