Jobs in Union County

About The Position

Requirements

• Bachelor’s Degree in Engineering or Science related field is required
• Minimum 2 years experience in continuous improvement, Operations SME, and/or Technical SME
• Quality, process and manufacturing investigation and technical writing experience is preferred
• Background in cGMP’s requirements is preferred
• Lean Six Sigma problem solving skills is preferred
• Experienced in Microsoft Office Word, Excel and PowerPoin t
• Ability to learn and navigate through investigation, quality and ERP systems
• Have flexibility to work various shifts times if needed to complete work content.
• Proficiency with English Language
• Models effective and constructive communication and interactions with technical departments both orally and in writing.
• Maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
• Requires a passion for problem solving, attention to detail, good interpersonal skills, a sound understanding of cGMPs and Manufacturing/ Packaging.
• Ability to interact with the operations personnel, QA GMP Services, Manufacturing Engineers, Records/Release, Quality Control, QA Regulatory, Engineering.
• Autonomously prioritizes daily tasks with little to no oversight and shows attention to detail

Responsibilities

• Proactively leads process improvements for Operations department
• Participates in quality incident response, including initial response and containment, and utilizes Practical Problem Solving tools and principles to aid in root cause analysis and identification of corrective actions.
• Facilitate discussions between cross-functional teams (Quality, Tech Services, Engineering, etc.) in order to drive alignment on quality incident root cause and correction actions.
• Aid in investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met.
• Performs final functional area approval for operations owned deviation investigation reports to ensure report accuracy and alignment on root cause and correction action(s).
• Support resolution of department critical corrections / facilitate alignment on process comments and batch records notes per cGDP.
• When appropriate, revise and maintain manufacturing procedures and forms to ensure GMP compliance.
• Support Manufacturing systems to proactively identify and address quality risks, including Daily Gemba process and Quality Suggestion Program.
• Track and analyze Quality metric data for Manufacturing department to drive RFT initiatives
• Participates in inspection readiness activities in Manufacturing Areas
• Author digital forms for executing setup/run/clean batch activity in Digital Logbook system

Benefits

• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement