Ops Quality Eng II

About the role

In a cGMP manufacturing setting, provide Process/Quality Engineering support to all areas of the facility to ensure delivery of the highest quality product to the customer. The Quality Engineer will provide statistical and process support to assist with continuous improvement activities.

Responsibilities

• Support various elements of the Quality System including Deviations (Exceptions), Supplier Quality, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, Validation, and identification/recommendations for continuous improvement opportunities (internal/external)
• Apply appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity
• Act as lead for Quality Systems ownership for day-to-day activities, support of the Quality function (QA) daily, and monthly metrics and trending
• Support compliance efforts for the site
• Support Quality system improvements and benchmarking of other sites to establish and implement best practices
• Participate in continuous improvement activities as required; may lead continuous improvement activities (e.g. kaizen)
• Work within production teams to develop data trending models using appropriate statistical methods and deploy use of them
• Analyze trends related to various activities and identify root causes and areas for improvement; utilize output of trend analysis to initiate investigations and/or corrective/preventive action projects
• Assess manufacturing and support processes to identify and implement quality minded efficiencies and improvements
• Lead or participate in risk analysis activities (FMEA) for changes to production or design processes; use process mapping tools to define critical control points and recommend alternatives to reduce risk of defects
• Support product complaint efforts including root cause analysis and CAPA
• Lead investigation efforts and accurately document investigation plans, supporting data, and conclusions
• Lead corrective and preventive action projects
• Participate on extended core teams as a QA representative
• Perform statistical analysis (Excel, Mini-tab, other statistical software)
• Develop sampling plans as needed
• Provide change management guidance and support
• Provide internal and external audit support as an SME
• Assist supplier quality oversight, including technical support for supplier selection and supplier quality evaluations as well as the development and management of supplier corrective action plans; work closely with suppliers to ensure quality expectations and strengthen supplier relationships
• Participate in a certified 5S Workplace System to ensure good housekeeping and organization
• Prioritize and plan workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy
• Effectively train, coach, and correct others in a positive manner

Requirements

• B.S. Degree in Chemical Engineering preferred; other degrees may be considered with relevant experience
• 1-5 years' experience in QA or a pharmaceutical manufacturing environment

Qualifications

• Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP
• Experience in root cause analysis and risk analysis
• Good project management, problem solving, team building, and negotiation skills
• Strong technical, oral, and written communication skills
• Able to speak, read, and write the English language
• Knowledge of Six Sigma Tools
• Ability to plan and execute tasks on multiple projects simultaneously
• Must strive for continuous improvements in all work activities
• Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing Command Skills, Action Oriented, Conflict Management, Customer Focus, Timely Decision Making, Functional/Technical Skills, Presentation Skills, Priority Setting, Dealing with Ambiguity, Written Communication

Working conditions

• Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment
• Exposure to fugitive emissions of chemicals typical for chemical operations
• Position may require some travel
• Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines