Job Details

  • Title: Clinical Supplies Operator
  • Code: RCI-11657247
  • Location: Fort Worth Texas (TX) 76136
  • Posted Date: 11/19/2020
  • Duration: 12 Months
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  Job Description

Job Purpose:

  • 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.

Education:

  • Minimum: BS or equivalent
  • Desirable: MS or equivalent

Experience:

  • 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