Ops Quality Eng II

Paladin Labs Inc.; Raleigh (NC); Ibrido; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Paladin Labs Inc. is seeking a Quality Engineer II in Raleigh, NC to interpret and apply regulatory requirements within a cGMP manufacturing setting.

The role provides process and quality engineering support, including statistical analysis and continuous improvement initiatives to ensure the highest product quality for customers. The ideal candidate has 1–5 years in QA or pharmaceutical manufacturing, knowledge of ICH guidelines, and strong communication skills.

Competenze

• B.S. Degree in Chemical Engineering preferred; other degrees considered with relevant experience.
• Experience in QA or pharmaceutical manufacturing environment (1-5 years).
• Knowledge of ICH Guidelines (Q7, Q8, Q9, Q10), FDA, EMA, USP, EP, JP.

Mansioni

• Interpret and apply applicable regulations and Quality Systems.
• Provide statistical and process support for continuous improvement.
• Lead or participate in CAPA, deviation investigations, and risk analyses.

Conoscenze

Quality systems

Root cause analysis

Six Sigma

Project management

Written communication

English proficiency

Formazione

B.S. in Chemical Engineering

Strumenti

Excel

Minitab

Descrizione del lavoro

## Ops Quality Eng IIApplylocations: Raleigh, NC (Pharma) - USA033time type: Full timeposted on: Posted Yesterdayjob requisition id: 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 analysisGood 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 ToolsAbility to plan and execute tasks on multiple projects simultaneouslyMust strive for continuous improvements in all work activitiesSelf-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, OrganizingCommand 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.