Technical Investigation Writer

Job Summary

Working remotely on a contract basis, the Technical Investigation Writer will investigate quality deviations in raw material dispensing and manufacturing operations, review GMP documents, and collaborate with cross-functional teams to ensure timely resolution of non-conformances.

Key responsibilities

• Investigate quality deviations and identify root causes using various analytical methods
• Collaborate with Technical Services, Engineering, and Manufacturing teams to assess the impact and risk of deviations
• Finalize investigation reports with QA Compliance and ensure timely implementation of CAPAs

Required qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Life Sciences, or a related scientific discipline
• 3-5 years of experience in regulated GMP manufacturing environments such as Pharmaceutical or Biotechnology
• Proven experience in conducting and documenting quality investigations and CAPAs
• Strong understanding of cGMP, FDA regulations, and industry standards
• Familiarity with Quality Management Systems and risk assessment methodologies