Technical Investigation Writer

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