Ops Quality Eng II

Par Health; Raleigh (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Par Health in Raleigh, NC is seeking a Quality Engineer to interpret regulations, support the Quality System, and provide statistical process support in a cGMP manufacturing environment. The role involves applying data-driven methods to identify root causes and drive corrective actions for quality improvements.

You will lead or participate in CAPA, deviation, OOS, and change control activities, collaborating with production teams and suppliers to ensure product quality and regulatory compliance

Qualifications

• B.S. Degree in Chemical Engineering is preferred, other degrees considered with relevant experience.
• 1-5 years’ experience in QA or a pharmaceutical manufacturing environment.
• Knowledge of ICH Guidelines (Q7/Q8/Q9/Q10), FDA, EMA, USP, EP, and JP.
• Experience in root cause analysis and risk analysis.
• Strong project management, problem solving, and teamwork skills.
• Excellent written and oral communication; ability to speak, read, and write English.
• Knowledge of Six Sigma tools.

Responsibilities

• Lead Quality System ownership for day-to-day QA activities and monthly metrics.
• Support GMP compliance and drive continuous improvement initiatives.
• Perform data trend analysis and apply statistical methods to identify root causes.
• Lead or participate in CAPA, deviation, OOS, and change control processes.
• Collaborate with production teams and suppliers to ensure quality across the site.

Skills

Root cause analysis

Six Sigma

Project management

Problem solving

Communication

English language

Data analysis

Statistical tools

Quality systems

Education

B.S. Degree in Chemical Engineering

Tools

Excel

Minitab

Job description

Raleigh, NC (Pharma) - USA033

Full time

R003284

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

The role provides support for the various elements of the Quality System, including but not limited to the following: 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). 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/ SCOPE

• This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt.
• This position interacts with personnel outside the company on a customer and supplier level.
• This position requires self-motivation and daily execution of tasks with limited supervision interaction.

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 wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Come join 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.