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Quality Assurance Engineer

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Beacon Hill

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Location:
United States , Noblesville

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

35.00 - 37.00 USD / Hour
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Job Description:

Beacon Hill Life Sciences is looking for a Quality Assurance Engineer to conduct investigations, handle change management, identify and implement continuous improvement opportunities, and maintain GMP compliance.

Job Responsibility:

  • Identify and implement Corrective Actions Investigate Exceptions (Deviations)
  • Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, Data Sheets, etc.
  • Employ the use of quality tools (i.e., FMEA, Fishbone, 5 Whys, Risk Analysis, HFAT, etc.) in support investigations and special projects
  • Perform analysis of data in support of investigations, cost savings, and continuous improvement initiatives
  • Work with radioactive materials
  • Ensure a safe, high-quality working environment through training, awareness, and compliance with safety/Quality guidelines and SOPs
  • Maintain current knowledge of US and international quality regulations
  • Author or perform peer review of annual product quality reviews
  • Provide support for regulatory agency on-site audits (e.g., FDA, HC, TGA, EU, etc.), as required
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Requirements:

  • Bachelor of Science in Biology, Chemistry, or related field required
  • 3 or more years of relevant experience required
  • Must be able to resolve problems, handle conflict, and make effective decisions under pressure
  • Ability to do simple to complex math calculations, input data into the computer, and analyze data as required
  • Must be proficient in the use of Microsoft Office suite products
  • Good computer skills, including utilizing personal computers and data entry programs
  • Good hands-on, analytical, problem-solving, and decision-making skills
  • Excellent writing and verbal communication skills
  • Ability to work independently and with others to accomplish goals and priorities
  • High energy level and regular, consistent attendance

Additional Information:

Job Posted:
December 23, 2025

Employment Type:
Fulltime
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