Mfg. Tech Trainer & RSO

0-2 years
2 months ago
Job Description

  • Coordinate New Hire Onboarding to provide adequate training on SOP s, Quality Management Systems including Good Document Practices (GDP).
  • Assist in training and troubleshooting for department s Learning Management System (LMS): Compliance Wire.
  • Follow relevant procedures to ensure all Training Records and reference documents are tracked.
  • Develop and compile weekly training compliance reports.
  • Ensure all Standard Operating Procedure (SOP) binders have the correct revision with the relevant SOP s for each Production Area.
  • Ensure that any revised change to a procedure is clearly communicated to the affected Production Area.
  • Work with the Area Supervisors and/or Production Lead to complete and provide On-the-Job training (OJT) and Cross Training requirements.
  • Assist in training on Planned Deviation Requests (PDRs) or Nonconforming Requests (NCRs) that will impact Manufacturing Operations
  • Develop, continuously assess, and revise interactive training curricula for New Hire Onboarding, OJT, as well as all other departmental training needs.
  • Work collaboratively with supervisors, engineers, analysts and all other support personnel to develop training curricula, update procedural changes, and provide adequate training.
  • Assess instruction effectiveness and summarize evaluation reports determining the impact of training on employee skills and how it affects Key Production Indicators (KPIs).
  • Provide Train the Trainer sessions for manufacturing trainers and SMEs.
  • Identify and communicate any gaps, needs, and plans of action for training curricula improvements.
  • Support and participate in audits for FDA, ISO, and any others as requested.
  • Perform weekly audits in manufacturing to ensure compliance, quality and safety.
  • Review and modify training curricula and/or user groups as necessary.
  • Monitor and follow up on all expired trainings, as well as pending and aged OJTs.
  • Develop and create necessary training modules in Compliance Wire or any other software system approved by Cepheid Danaher.
  • Assist Document Specialist on required trainings during change control process in Agile.
  • Assist with the day-to-day training needs in absence of other team members.
  • Assist with other projects as needed in support of Manufacturing Operations.

As RSO

  • Implement the safe procedure for operation of the device specified below, on first time receipt
    • ensure that source containment has all of its components intact and in an acceptable condition.
    • radiation dose rate profile in the vicinity of the source containment conforms to the limits specified by AERB
    • shutter or source control mechanism, source assembly and retraction mechanism and any other safety features operate correctly and safely
    • radiation warning signs and labels are intact, appropriately marked and legible o device performs satisfactorily when used in accordance with manufacturers instructions.
    • location of the gauge has not been altered without the approval of the Competent Authority
  • Ensure Implementation of Safe Work Procedure

JOB TYPE

Industry

Other

Skills

Key Production Indicators
Quality Management Systems
Training Records
Fda
Iso
On-the-Job training
Nonconforming Requests
Good Document Practices
Sop
Planned Deviation Requests
Compliance Wire

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