Technical Writer for Investigations

Job Summary

To support quality assurance efforts, the contract Technical Writer for Investigations will investigate quality deviations in manufacturing and packaging operations, review GMP documents, and collaborate with cross-functional teams while working remotely.

Key responsibilities

• Investigate quality deviations during raw material dispensing and manufacturing processes
• Review GMP documents to identify root causes of reported deviations and propose corrective actions
• Collaborate with Technical Services and QA Compliance teams to finalize investigation reports 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 authoring GMP documentation
• Strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations
• Familiarity with risk assessment methodologies and Quality Management Systems (QMS)