Jt- Manufacturing Senior Associate

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

• Lead and support manufacturing continuous improvement initiatives using Lean, Six Sigma, and DMAIC methodologies to improve safety, quality, delivery, and cost performance.
• Independently execute small to mid scale CI projects, from problem definition through implementation and sustainment
• Collect, analyze, and interpret manufacturing performance data to identify trends, root causes, and improvement opportunities
• Apply structured problem solving tools (e.g., 5 Whys, Fishbone, Pareto analysis) to resolve operational issues and prevent recurrence
• Develop, update, and improve standard work, work instructions, and visual management to ensure consistent execution
• Partner with Manufacturing, Engineering, Quality, Maintenance, and other support functions to implement cross functional improvements
• May own major and trend deviations to support identifying root cause and will also participate in multi-functional conceptualization of design solutions (CAPAs).
• Maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and supply to product/process improvement
• Lead root cause analysis to identify the failure mode
• Identify root cause using tools such as fishbone diagrams, 5 Whys, KT, Process mapping, and risk assessments such as FMEA’s or Fault Tree Analysis
• Applies knowledge and subject matter expertise to ensure end-to-end of investigations
• Lead discussion to reduce, correct, mitigate and prevent the reoccurrence of the event based on output of root cause analysis
• Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports
• Generate final technical reports, which may include data collection and statistical analysis of the data

• Associate degree preferred
• 1-2 years of proven ability in investigation process.
• Strong technical writing
• Lean / Six Sigma continuous improvement experience (DMAIC, root cause analysis)
• Data driven problem solving
• Experience developing kaizens, standard work, work instructions, and visual management
• Proven Six Sigma proficiency specifically for root cause analysis methodology
• Understanding and application of Drug Substance process, data mining, quality and compliance.
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Project Management experience
• Able to influence tri-functional team and interpersonal leads for this position
• Available for day shift