- Title: Clinical Supplies Operator
- Code: RCI-11657247
- Location: Fort Worth Texas (TX) 76136
- Posted Date: 11/19/2020
- Duration: 12 Months
Talk to our Recruiter
- Name:Vishal Trivedi
- Email: email@example.com
- Phone: 908-704-8843 ✖ 435
- Under daily supervision, supports the aseptic set up, sanitization, manufacture (compounding, fill) and finishing (label, bulk shipment) of sterile clinical products according to cGMP requirements.
Basic Major Activities:
- 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. Fulfil 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 company's 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 company's 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.
Operational Development Specific Activities:
- 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
- Support all, and lead multiple activities related to assigned projects
Key Performance Indicators:
- Accountability for costs, quality, quantity, and timelines for all assigned tasks.
- Adherence to company’s standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
- Feedback from other team members/leaders.
- Refer to annual individual and team objective setting.
- Outcome of risk analyses, process challenge meetings, audits and inspections.
- Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
Impact on the organization:
- Actively contributes to Supply Team objectives by delivering quality clinical supplies according to established timelines with supporting GDP compliant documentation according to company’s QM, SOP, global regulations.
- Minimum: BS or equivalent
- Desirable: MS or equivalent
- Minimum 0-4 years (for BS) or 0-2 years (for MS).
- Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
- Knowledge of cGMP and Annex 13 requirements
- Strong scientific and technical knowledge skills: in product manufacturing, sterile garbing, sanitization, warehousing / logistics and inventory management.
- Prior experience in aseptic processing of liquid products in a GMP, audited facility
- Proficient with equipment and/or instruments.
- Demonstrating leadership behaviors through positive words and actions.
- Adequate knowledge of software and computer tools.
- Basic presentation skills and scientific/technical writing skills
- Good communication skills