The Fountain Group Fort Worth, TX
- Expired: over a month ago. Applications are no longer accepted.
My name is Casey Ashley, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Manufacturing Associate for a prominent client of ours. This position is located in Fort Worth TX. Details for the position are as follows:
- Supports the aseptic set up, sanitization, manufacture (compounding, fill) and finishing (label, bulk shipment) of sterile clinical products according to cGMP requirements.
- Demonstrate a good working knowledge of the GMP requirements associated with the cleaning, changeover, setup, startup, operation, breakdown, sanitization and sampling of compounding areas and filling lines for sterile clinical products.
- Demonstrate good aseptic technique and understanding of sterile garbing requirements.
- Demonstrate good documentation practices according the cGMP requirements for all records. .
- Perform visual and physical inspections of in process and finished products as requested
- Operate under the direct supervision/leadership of a Lead Operator and/or Supervisor
- Assist in labeling, packaging and shipment of bulk finished goods to GCS
- Actively participate in teams, projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own discipline.
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
- Plan, perform, monitor and report all operational activities.
- Meet quality, quantity and timelines in all assigned projects, networks and/or platforms.
- Proactively contribute requested cost information for projects/networks.
- Work according to appropriate SOP’s, GLP, GMP, QM, QD, HSE, ISEC and Novartis guidelines.
- Report data, and align with team and leaders to draw relevant conclusions and write reports.
- Support quality of clinical supply products through generation of documentation that provides clear evidence of compliance with Novartis QM, QD and global regulations.
- Interact/collaborate with other functions in Development to facilitate transfer of knowledge and deliverables with the production of clinical supplies.
- Identify need and opportunity for outsourcing. Provide input to contracts and QA-agreements with 3rd parties and lead outsourced tasks/projects with 3rd parties as appropriate.
- Monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken.
- Plan, perform and contribute to project batch production by proactively considering potential issues associated with equipment, instruments, and processes to allow resolution prior to initiation.
- Create and implement efficient and robust procedures/processes for the manufacture of clinical products
- Plan, create and execute appropriate change control management according to SOP and QM requirements
- Coordinate with team members to ensure all activities required to support batch are successfully completed to maintain scheduled batch activities
- Proactively provide ideas to enhance efficiency and/or effectiveness of operations.
- Report and present own work at internal meetings
- Demonstrate compliant GDP in all GMP records
If you are interested in hearing more about the position please respond to this posting with your resume attached.
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
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 Group
Looking 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