QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices and manufacturing industry, is looking for a talented, highly motivated and enthusiastic Specialist Manufacturing 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.You'll be a fit for this job if you have:Bachelor’s degree in Life Sciences or Engineering.5 years of Manufacturing Operations experience.Non-Standard Shift Support.Spanish/ English.In this position you'll: 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.Provide troubleshooting support.Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.Ensures that processes, and procedures are compliant with cGMP requirements and/or other applicable regulations.Support Risk assessment tasks.Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training.Continuous process monitoring to implement process enhancement.Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.Own Change Control and ensure implementation within established goal.Assist manufacturing change owner on CCRB packages impacting the process.Own Change Control and ensure implementation within established goal.Participate in noncommercial activity runs to support the collection and analysis of process data.To get hired at QUALITY CONSUTING GROUP, you MUST be:Root Cause AnalysisProcess ExpertiseSupport trouble shooting to identify Causal Factors and potential corrections.Evaluate manufacturing and operational procedures.Evaluate training requirements for technical aspects of the process.Identify training opportunities.CAPAs.Evaluate process improvement opportunities.Negotiate Actions with Stakeholders.Deliver timely robust plan to address Root Cause.Perform Impact to Process /Equipment /System Assessment.Team with Product Development to understand potential impact to product quality attributes.Assess Equipment/Systems information for potential impact to product quality attributes.Assess for Data Integrity.Assess for Process/Cleaning Validation Impact.Author Investigation Report.Use Technical Writing techniques proficiently.Perform Data Verification.Ensure timely report approval.Support Peer Review.Follow current standard procedures/templates.Serve as SME to define deviation designation when called upon.Participate in regulatory inspections.Participate in the assessment or implementation of special projects or initiatives.New Product Introduction.Packaging Process.Change Control Processes.Equipment Modification/ Troubleshooting.The details:We're a growing 60+ person company.We are actively looking for the best candidate.We accept applications and RESUME’s.Powered by JazzHR
