Job Description
Responsibilities
- Investigate and author reports on a range of deviating conditions or nonconforming events across multiple technical departments in collaboration with subject matter experts.
- Gather, analyze, and interpret information to provide evidence supporting investigation conclusions and root-cause determinations.
- Utilize analytical tools and methodologies to identify root causes and contributing factors.
- Develop robust corrective and preventive actions, including the use of automation and engineering controls to strengthen processes and reduce risk.
- Translate complex technical information into clear, concise, and accessible written documentation.
- Collaborate with internal and external stakeholders to present investigation findings in a logical, comprehensive, and accurate manner.
- Review historical deviations and adverse events to identify trends and recommend proactive prevention strategies.
Qualifications
- Bachelor’s degree in a scientific, engineering, or technical field.
- At least 3 years of technical writing experience within a regulated GMP environment, ideally in pharmaceutical, biopharmaceutical, or biotechnology settings.
- Strong ability to work collaboratively with cross-functional teams and communicate complex information effectively to varied audiences.
- Demonstrated proficiency in producing clear, accurate, and high-quality technical documentation.
- Solid understanding of GMP manufacturing processes and regulatory expectations (preferred).
- Excellent organizational skills and attention to detail.
- Familiarity with documentation tools and electronic document management systems (EDMS) (preferred).
- Strong computer skills, including intermediate to advanced proficiency in Microsoft Word and Excel.
- Ability to manage multiple projects and meet deadlines in a dynamic environment.