Jt069 - Manufacturing Sr. Associate

QUALITY CONSULTING GROUP, a leader in the 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.

Responsibilities:

• 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

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.