Entry Level Quality Assurance Analyst Jobs in Puerto Rico

To lead a shift within a business unit in the delivery of manufacturing performance targets for customer satisfaction, quality, costs and production in a safe working environment.

• Safety Regulation knowledge

• Knowledge of ISO 9000

• Good oral and written communication skills

• High level of verbal, numerical and diagrammatical reasoning ability

• Effective people management skills in a team working culture

• Computer knowledge

• Excellent interpersonal skil

• Applies communication skills to perform work and coordinates with others

• Utilizes vision all the time in all aspects (close, distance, focus, etc.)

• Utilizes a high analytical capacity and high level of professionalism and judgment to resolve problemsApplies communication skills to perform work and coordinates with others

• Utilizes vision all the time in all aspects (close, distance, focus, etc.)

• Utilizes a high analytical capacity and high level of professionalism and judgment to resolve problemsls.  Highly motivated, self-starter, and responsible person

Experience:

• Six to Ten years or more of experience in medical devices/pharmaceutical industry in a similar position 

Education:

• Bachelor degree in Business Administration or Industrial Engineering 

• Generating NCR for non-conforming materials

• Initiating Non-Conformance Resolution

• Evaluating NCR 

• Identifying resources availability for Manufacturing

• Production Line set-up

• Dry process batch release 

• Preparing Wet batch record

• Assuring production goals are achieved for Manufacturing

• Implementing Safety corrective actions

• Improving Safety unit indicators

• Waste Disposition to Satellite Station

• Identifying process and/or Mft. equipment not performing as expected

• Ensuring correct resources are acting upon situation for Mfg

• Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer

• Working Order Cycle 

• WIP Management

• Supply Chain Performance Indicators Management 

• Supply Chain Performance Indicators Improvement 

• Labor Cost (Budget/ Forecast) 

• Unit RM Usage Optimization

• Quality Awareness

• Implementing Corrective / Preventive Actions 

• Investigate NCR 

• Completion of NCR

• Providing Training for QI

• Processing Dry batch 

• Processing Wet batch

• Creating safe conditions by design 

• Identification of no safe set-up

• Continuous education of unit members in Safety 

• Safety Awareness 

• Safety daily monitoring Audits 

• Ensuring completeness of unit investigations of accidents 

• Managing Safety Emergencies issues 

• Measuring Safety unit's indicators 

• Creation troubleshooting guidelines and/or applicable SOPs for process and equipment maintenance and repairs 

• Identifying possible causes of variation/failure/ under performance 

• Document diagnostics, solution method and impact in troubleshooting for Mft. 

• Measuring Process KPI's for improvement 

• Designing and Coordinating Engineering Tests / Q's 

• Executing Engineering test / Q's 

• Documenting and Reporting results of Engineering tests/ Q's 

• Assuring readiness of Manufacturing requirements for the Product Transfer

• Assuring Operator and BU's resources have the skills and knowledge coming from change due to Optimizations

• Implementation of Optimizations Efforts

• Executing TPM/ PM/ PDM activities in Mft. according to schedule 

• Verifying TPM/ PM/ PDM tasks effectiveness in Mft.

• Ensuring correct resources are acting upon situation for equipment repair

• Identifying possible causes of variation/failure/ under equipment performance for Mft

• Measuring equipment efficiency 

• Identifying opportunities for Improvements in equipment performance 

• Implement Equipment's Upgrades and Optimization Changes 

• Document all Equipment Changes 

• Employee Support 

• Manage employee conflicts 

• Assure information flows 

• Promote a good work environment 

• Skills Development for BU's Members 

• Audit/ Compliance (physical) for skill certifications 

• Technical Academy design and delivery 

• Proactive Human Resources Intervention 

• Alive HR advice 

• Monitoring Unit Performance 

• People Development

• Assuring Adherence to value 

•  

• Actively Participates in: 

• Scheduling (Proactive Operational Planning) 

• Reporting Production Metrics

• Inserts Inventory Supplies 

• Analyzing cost per unit budget 

• Quarterly Forecast 

• Unit MRO, Incl. Spare Parts Usage Optimization

• WIP and FG Inventories Targeting $'s 

• Year and physical inventory 

• Material Quality issue avoidance 

• Define tactics for Quality First pass, DMP & CPM Metric (Once a Year) 

• Monitor Supplier 's Performance 

• Performing Lot Document Spot Screening 

• Performing Daily Monitoring Audits (In process only) 

• Investigation (Data gathering QA issues)

• Identifying corrective/ preventive actions

• Non-Conformance WIP Management

• Investigating QA Feedback and complaints 

• Investigate Complaints 

• Develop actions to improve QA KPI's 

• Lead QA Improvement Activities   

• Providing support for the QI Start-up 

• Coordinate production improvements implementation 

• In line spot screening 

• Safety non-conformance Resolutions

• Defining and prioritizing Process KPS's for improvement 

• Analyzing through a structure approach to identify root causes 

• Improving Process KPI's performance 

• Developing controls mechanism to ensure Process KPI's consistency 

• Providing technical solutions that increase utilization and reduce costs

• Minimizing service interruptions and avoid unplanned downtime on manufacturing lines 

• Receiving and implementing Product and Equipment Transfer

• Observing, Analyzing, Documenting & Recommending the Start-up of product transfer

• Early involvement in LS/ Optimization Efforts with technical innovation (ROI)

• Assuring readiness of manufacturing requirements for the Optimization Changes 
• Observing, Analyzing, Documenting & Recommending the Start-up of Optimization Changes 

• Correct troubles in Mft. under performance situation using troubleshooting guidelines and/or applicable SOPs

• Assuring Compliance with Laws & Regulations

• Payroll Administration Kronos

• Vacations & Overtime Administration for Non- Exempt

• Generating Purchases Requisition

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