Quality Assurance Analyst (Durham) Job at Medasource, Durham, NC

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  • Medasource
  • Durham, NC

Job Description

Our global pharmaceutical manufacturing client in RTP is expanding rapidly, manufacturing and packaging millions of injectable each week. With growth comes responsibility, and were seeking Complaint Investigators to join the Quality team to ensure every product meets the highest standards of safety and compliance.

This role is critical to patient safety: youll investigate product complaints, review data, determine root cause, and ensure every case is closed in compliance with GMP regulations.

What Youll Do

  • Conduct thorough investigations into product complaints (device malfunctions, product quality issues).
  • Review manufacturing and quality data to identify potential root causes.
  • Document investigations clearly and ensure closure within regulatory timelines.
  • Work with manufacturing and technical services to gather facts and verify findings.
  • Defend product quality by ensuring checks and balances are in place.
  • Support continuous improvement of complaint investigation processes.

Must-Have Qualifications

  • Quality mindset : Prioritizes compliance, documentation, and patient safety over speed or convenience.
  • Investigation experience : Background in pharmaceutical manufacturing investigations (complaints, deviations, CAPAs, or similar).
  • Quality systems knowledge : Understanding of GMP expectations, root cause analysis, and QMS processes.
  • Documentation rigor : If it isnt documented, it didnt happen.
  • Integrity : Willing to escalate or stop processes to protect quality.

Preferred Skills

  • Experience with electronic Quality Management Systems (Veeva or similar).
  • Bachelors degree in science/engineering (or equivalent industry experience).
  • Strong analytical, writing, and problem-solving skills.
  • Curious, detail-oriented, and independent able to drive investigations to completion.

Job Tags

Part time,

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