My name is Josh Stock and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Deviation/ Investigation Writer for a prominent fortune 500 client of ours. This position is located in Worcester, MA. Details for the positions are as follows:
- Write SolTRAQs (TrackWise) exception reports for operations
- Ability to independently manage assignments and shifting priorities while maintaining timelines
- Lead meetings and influence others to gain consensus across multiple departments
- Identify trends and propose effective CAPAs
- Anticipate roadblocks and elevate as appropriate
- Possess strong technical writing skills
- Strong computer skills, including Microsoft Word and Excel.
- Bachelor’s degree in science or related field
- Minimum 3 years’ experience in FDA regulated environment in area such as manufacturing, quality, engineering, process development or quality control
- Strong understanding of biologics processes and quality systems
- Ability to work collaboratively with different teams and stakeholders
- Effective communicator
What are the top 3-5 skills requirements should this person have?
- Strong Understanding of Biologics Manufacturing Processes and Quality Systems
- Strong Technical Writing Skills
- Ability to independently manage workload and shifting priorities
- Effective Communicator with team members from different departments
- Lead meetings and influence others
- Previous experience writing exception reports (also referred to as investigations or deviations in other companies)
- Previous experience working with TrackWise, LIMS, Maximo and Learning Management Systems
What type of environment is this person working in?
- Group setting – Rarely, especially until all personnel have returned to site (team is currently 100% remote)
- Individual Setting – 90% of the time
- Combination of both
If you are interested in hearing more about the position, please respond to the email address with your resume attached
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field
The Fountain GroupLooking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field