Ops Quality Eng II

Endo•Raleigh, NC

8d•Hybrid

About The Position

The Quality Engineer has responsibility for interpreting and applying the applicable regulations and Quality Systems. 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.

Requirements

B.S. Degree in Chemical Engineering is preferred, other degrees may be considered with relevant experience.
1-5 years’ experience in QA or a pharmaceutical manufacturing environment
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, Problem Solving, Priority Setting, Dealing with Ambiguity, Written Communication

Responsibilities

Provides support for the various elements of the Quality System, including but not limited to: 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).
Applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity.
Acts as lead for Quality Systems ownership for day-to-day activities, support of the Quality function (QA) daily, and monthly metrics and trending.
Supports compliance efforts for the site.
Supports Quality system improvements and for benchmarking of other sites to establish and implement best practices.
Participates in continuous improvement activities as required.
May lead continuous improvement activities (e.g. kaizen).
Works within production teams, develop data trending models using appropriate statistical methods and deploy use of them.
Analyzes trends related to various activities and identify root causes and areas for improvement.
Utilizes output of trend analysis to initiate investigations and or corrective/preventive action projects.
Assesses manufacturing and support processes to identify and implement quality minded efficiencies and improvements.
Leads or participates in risk analysis activities (FMEA) for changes to production or design processes.
Uses process mapping tools to define critical control points and recommend alternatives to reduce risk of defects.
Supports product complaint efforts including root cause analysis and CAPA.
Leads investigation efforts and accurately document investigation plans, supporting data, and conclusions.
Leads corrective and preventive action projects.
Participates on extended core teams as a QA representative.
Develops sampling plans, as needed.
Provides change management guidance and support.
Provides internal and external audit support as an SME.
Assists 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.
Works closely with suppliers to ensure quality expectations and strengthen supplier relationships.
Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
Effectively trains, coaches, and corrects others in a positive manner.