Analysis Skills, Biology, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Data Processing, Documentation, Identify Issues, Manufacturing, Manufacturing Operations, Manufacturing Systems, Operational Audit, Operational Support, Operations Processes, Performance Analysis, Process Analysis, Process Development, Process Improvement, Process Validation, Product/Service Launch, Project/Program Management, Reporting Skills, Requirements Management, Root Cause Analysis, Secondary School, Set Goals, Systems Analysis, Technical Writing, Trend Analysis, Validation Plan
Inteldot has over 15 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.
Admin Shift | 8am to 5pm - OT based on business needs
Description:
With minimal supervision, 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.
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
Responsibilities:
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
- Support 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 goal.
- Review equipment/system Root Cause Analysis investigations and support trend evaluations.
- Assist with generation 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.
Education:
Doctorate or -Master's + 2 years of Manufacturing Operations experience or Bachelors + 4 years of Manufacturing Operations experience or Associates + 8 years of Manufacturing Operations experience or High school/GED + 10 years of Manufacturing Operations experience