Position: Technical Writer
& GMP Trainer
Department: Quality Assurance
Reports to: Quality Management
The Technical Writer & GMP Trainer role is responsible for
independently investigating and reporting on deviations to the
manufacturing process, customer complaints on the finished product,
and other manufacturing problems as assigned. Also, to provide
continuous coaching and training to all plant personnel to ensure
FDA regulations are being followed within their job function.
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
& complaints 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
Writes Impact Assessments and Investigation Reports, works
within paper based and Master Control
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 management.
Assist in preparing Quality SOP’s, protocols, and reports.
Utilizes Word, Excel, Master Control and other electronic
systems to complete tasks.
Assist department management in increasing effectiveness of
job specific GMP related training
Deliver required recurring GMP trainings to all plant personnel.
Conduct needs analysis to determine GMP training needs
(includes tracking training deviations and CAPA’s -corrective and
Assist with the development and collation of training
materials, job aids, checklists and any other materials necessary
to deliver training.
Maintain and manage all training files and the collection of
training attendance records as it relates to GMP and SOP’s.
Perform daily walk-throughs within the plant to identify and
deliver on training opportunities.
Create and update SOP training plans by position.
Deliver GMP New Hire Orientations & Annual GMP training
Provide monthly reports which illustrate the areas of training
opportunities and action steps taken for learning and improvement.