harbaheadercoverblack.png

Quality Assurance Specialist

Indianapolis $75,000 - $95,000 Permanent

Key Responsibilities:

  • Investigate and document deviations and nonconforming events across multiple technical departments
  • Gather and analyze data to support root cause investigations using tools such as 5 Whys and Fishbone
  • Collaborate with Manufacturing, Engineering, MS&T, Supply Chain, and Quality teams to ensure accurate and thorough investigations
  • Translate complex technical processes into clear, concise investigation reports and documentation
  • Develop and support corrective and preventative actions (CAPA) to address root causes and prevent recurrence
  • Review historical deviations and quality events to identify trends and support continuous improvement
  • Maintain documentation within electronic Quality Management Systems (eQMS) and ensure compliance with GMP standards

Qualifications:

  • Bachelor’s degree in a scientific, engineering, or technical discipline
  • 2+ years of experience in quality assurance or technical writing within a GMP-regulated environment (pharmaceutical, biotech, or biologics preferred)
  • Experience with deviation investigations, root cause analysis, and CAPA development
  • Strong understanding of GMP manufacturing processes and regulatory requirements
  • Excellent technical writing, documentation, and communication skills
  • Proficiency with Microsoft Word and Excel, and familiarity with electronic document management systems (EDMS) or eQMS
  • Strong organizational skills and attention to detail, with the ability to collaborate across teams
Share this job:

Apply now

Similar Jobs

Facilities Technician

Indianapolis $28 - $35 p/h Contract

Key Responsibilities Follow all applicable quality systems, policies, and procedures to ensure products meet safety, quality, and regulatory sta...

Quality Control Technician

St. Louis $20-$22/HR Contract

Job Responsibilities: Perform routine laboratory testing of raw materials, in-process samples, and finished products using established ana...

Microbiology Technician

St. Louis $20-$22/HR Contract

Job Responsibilities:  Perform environmental monitoring in cleanroom and controlled manufacturing areas, including viable air sampling, sur...

Production Technician

Indianapolis $17.75 - $18.50/HR Contract

Job Overview: We are seeking a Production Technician who is responsible for the accurate assembly and packaging of diagnostic kits that are essenti...

Operations Engineer

Indianapolis $85,000 - $95,000/YR Permanent

Job Overview: We are seeking an Operations Engineer to support manufacturing activities within a regulated sterile drug product environment. This po...