Inteldot has over 13 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Description:
Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Administrative Shift.
Responsibilities:
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance by observing floor operations and reviewing performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
- Support the establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
- Responsible for managing NC/CAPA closure within established goals.
- Review equipment/system Root Cause Analysis investigations and support trend evaluations.
- Assist with the generation and execution of process validation protocols and reports.
- Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
- Assist manufacturing change owner on CCRB packages impacting the process
Competencies / Skills:
- Experience in handling deviations/non-conformances investigations.
- Skills for technical writing and development of reports.
- Knowledge and experience with root cause analysis tools (e.g. causal factors analysis, 5 Why’s).
- Project management skills on identifying/tracking actions and achieving due dates.
Education:
Master's degree and 3 years of Manufacturing Operations experience or Bachelor's degree and 5 years of Manufacturing Operations experience