Technical Writer

Overview:

In this role, you will be responsible for leading investigations for Engineering and Validation deviations, along with being involved in applying process, quality, compliance, and analytical knowledge to complete the following:

- Ensure Non-conformance are triaged within the established goals and serve as a deviation owner for minor and major deviations.

- Initiates and manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs and EV’s, completing product impact assessments, prior occurrence reviews and authoring investigation reports.

- Own corrective /preventative actions and effectiveness verification.

- Update and maintain F&E procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

- Present investigations to regulatory inspectors and internal auditors. Provide back-room support during on-site regulatory inspections.

- Oversee F&E audit readiness activities and track tasks to completion. Represent F&E function at Site Inspection Steering Committee meetings.

- Generate Quality and Safety metrics for F&E function. Provide reports on quality and safety compliance.

- Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. improvements, compliance topics and change control GDEs

- Assist with generation and execution validation protocols and reports. 

EDUCATION

B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.

EXPERIENCE

3+ years' experience in a similar role

COMPETENCIES/SKILLS

- Detailed technical understanding of manufacturing/engineering unit operations.

- Skilled in performance of GMP production operations

- Regulatory knowledge and interactions

- Ability to lead cross-functional teams

- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.

- Excellent organizational, technical writing and presentation skills.

- Good project management skills.

- Basic knowledge of control charting.