Ops Quality Eng II

Endo Pharmaceuticals; Raleigh (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

Par Health in Raleigh, NC, is seeking a Quality Engineer to interpret regulations and Quality Systems in a cGMP manufacturing environment. You will provide statistical and process support to drive continuous improvement and deliver the highest quality products to customers.

The role requires applying statistical tools, leading Quality Systems activities, supporting site compliance, and collaborating with production teams to identify root causes, implement CAPAs, and advance risk analyses and

Qualifications

• Education: B.S. Degree in Chemical Engineering preferred; other degrees considered with applicable experience.
• 1–5 years in QA or pharmaceutical manufacturing environment.

Responsibilities

• Deviations and exception handling
• Supplier quality management and audits
• Product complaints and CAPA
• Internal audits and 5S housekeeping
• Use statistical tools to analyze data and support continuous improvement
• Lead or participate in risk analyses (FMEA) and change controls

Skills

Quality Systems

Statistical Analysis

Root Cause Analysis

CAPA

Six Sigma

Process Improvement

Education

B.S. Degree in Chemical Engineering

Tools

Excel

Minitab

Job description

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

Job Description Summary

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.

Job Description

ESSENTIAL FUNCTIONS :

• Deviations (Exceptions)
• Supplier Quality
• Product complaints
• Internal Audits
• OOS
• CAPA
• Annual Product Review
• Process control
• Change Control
• Validation
• identification/ recommendations for continuous improvement opportunities (internal/external)

The Quality Engineer 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.

Additional functional requirements

• 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.
• Statistical analysis (Excel, Mini-tab, other statistical software).
• 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.
• Work closely with suppliers to ensure quality expectations and strengthen supplier relationships.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS

• Other duties as assigned with or without accommodation.
• 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.

MINIMUM REQUIREMENTS

Education: B.S. Degree in Chemical Engineering is preferred, other degrees may be considered with relevant experience.

Experience: 1-5 years' experience in QA or a pharmaceutical manufacturing environment

Preferred Skills/Qualifications

Other Skills/Competencies

• 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

RELATIONSHIP WITH OTHERS/ SCOP