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
