- Investigation writing
- Deviation investigations
- Manufacturing deviations
- Root cause analysis
- Investigation reports
The Technical Writer is responsible for independently investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
* Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.
* Responsible for managing multiple deviation investigations simultaneously.
* Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.
* Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.
* Works with process experts and production personnel to fully understand and solve problems,
* Provides technical expertise and recommends improvements. * Writes Impact Assessments and Investigation Reports, works within TrackWise.
* Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.
* Performs continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.
*Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.
* Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.
* Maintains compliance with company policies, training requirements, cGMPs and safety standards.
* BS/BA degree (experience may be considered in lieu of degree).
* Must have at least three years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports
* Requires advanced critical thinking skills
* Must be familiar with regulatory (FDA) requirements
* Good organizational, communication, and interpersonal skills are necessary
**What will this person be doing on a daily basis? What will be their daily responsibilities?
- MUST HAVE:
- Investigation piece and formulating investigations and putting procedures and thoughts done on paper and identify root cause
- Knowledge of the aseptic system
- Experience with Trackwise
- Manufacturing background is preferred not required
- Aseptic manufacturing background
- Written investigations
- Know the fishbone, identify capas, root analysis