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Biotechnology Investigator Writer Specialist
1 month ago
**Job Summary:**
We are seeking an experienced Biotechnology Investigator Writer Specialist to join our team. The successful candidate will be responsible for conducting thorough investigations, identifying root causes, and implementing corrective actions to prevent recurrence in a cGMP environment. This role requires strong technical writing skills, ability to work independently, and excellent communication skills.
**Key Responsibilities:*
- Conduct detailed investigations into process deviations, identify root causes, and implement corrective actions to prevent recurrence
- Develop and maintain accurate and comprehensive investigation reports
- Collaborate with internal teams and external clients to address comments and concerns
- Gather data from various sources, perform root cause analysis, and assess event impact on SISQP
- Identify and implement corrective and preventative actions to reduce deviation recurrence
- Perform risk assessments and trending analysis
- Facilitate meetings and align internal review teams and subject matter experts
- Conflict resolution and problem-solving in a cross-functional setting
- Manage multiple projects and timelines concurrently
Requirements:
We require the following qualifications for this role:
- Bachelor of Arts/Science or equivalent combination of education minimum
- Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline
- 1-3 years' experience; Prior experience in technical writing and manufacturing environment preferred
- Ability to work in a fast-paced, high workload environment and manage multiple projects and objectives
- Strong communication and interpersonal skills, both verbally and written
- Proven logic and decision-making abilities, critical thinking skills
- Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
Estimated Salary: $60,000 - $80,000 per annum
Duration: 12 months. Option to extend depending on business needs.
