Quality Technician - Azer Scientific

MidAtlantic Employers' Association; Morgantown (PA); Presencial; USD 52.000 - 76.000; Jornada completa

Descripción de la vacante

Azer Scientific in Morgantown, PA is seeking a Quality Tech to join our Quality Control team. You will monitor production processes, perform QC testing, inspections, and report results to ensure products meet established requirements and regulatory standards.

You will lead actions to prevent nonconformities, maintain CoAs, support calibration, and document quality procedures. Strong English communication and cGMP experience are essential for success, with collaboration across cross-functional

Formación

• Technical education or 5+ years of cGMP experience.
• Excellent written and communication skills in English.
• Experience in a QC/QA role, preferably in manufacturing, cGMP, production or chemistry.
• Familiarity with statistics and methods for quality improvement.
• Organized, proactive approach with ability to prioritize tasks and meet deadlines.
• Ability to collaborate with cross-functional teams.
• Knowledge of QMS standards (ISO 9001/13485) and GMP/FDA requirements is a plus.

Responsabilidades

• Perform QC testing and report results; confirm compliance with established requirements
• Perform in-process and final inspections
• Lead Nonconforming Product and related activities internally and with Vendors
• Create, revise, and maintain Quality documents
• Provide training on quality control processes and best practices
• Support calibration and maintenance of QC equipment
• Process customer returns as needed
• Manage the QC laboratory, consumables, equipment maintenance and calibration

Conocimientos

English proficiency

QC/QA experience

Statistical analysis

Organizational skills

Cross-functional teamwork

QMS ISO 9001/13485

Analytical skills

Educación

Technical education

Descripción del empleo

With over 30 years of laboratory expertise, our team atAzer Scientific is knowledgeable, motivated, andeager to assist you.

We are here to provide technical support and detailed productinformation to ensure our customers are getting the products to bestsuit their application.

We understand the crucial role that laboratory professionalsplay in the diagnosis, treatment, and research of diseases, and wewant to ensure that they have the best products available to them asthey continue to make a difference in the lives of patientseverywhere.

Position Summary:

The Quality Tech is responsible for the Quality Controlactivities, monitors production processes, nonconforming productsinitiatives, implements actions to ensure all finished productscompliance with quality standards, customer requirements and regulations.

The Quality Tech will report to Director of Quality andRegulatory Affairs and will collaborate with cross-functional teamsto identify areas for improvement and drive continuous improvement initiatives.

Duties & Responsibilities:

• Perform QC testing and report results; confirm compliance with established requirements
• Perform in-process and final Inspections
• Perform Work Order Closure according to QMS requirements
• Supervise the creation of certificates of analysis [CoA]
• Support on Inventory accuracy and lot traceability procedures
• Lead the Nonconforming Product and related activities[internally and with Vendors]
• Initiate and lead actions to prevent the occurrence of nonconformities relating to product, process, and QMS.
• Report quality and nonconformance data and trends to Quality Manager
• Manage the QC laboratory, consumables, equipment maintenanceand calibration
• Support on calibration process of internal devices
• Process Customer Returns, as needed
• Create, revise, and maintain Quality documents, as necessary
• Provide training and guidance to employees on quality controlprocesses, standards, and best practices
• Support on New product design process and be able to discuss /update Product specifications and raw materials, as necessary
• Perform other duties as assigned.

Education:

• Technical education or minimum 5+ years of cGMP workenvironmental experience

Experience and Skills:

Skills & Qualifications:

• Excellent written and communication skills in English
• Proven experience in a QC or QA role, preferably in a manufacturing, cGMP, production or chemistry environment.
• Familiarity with mathematics, statistical analysis tools and techniques for quality improvement
• Organized, proactive approach with the ability to prioritize tasks, work under pressure, and meet deadlines.
• Effectively collaborate with cross-functional teams
• Knowledge of QMS standards, as ISO: 9001 and or ISO:13485, and GMPand FDA regulatory requirements is a plus
• Excellent problem-solving and analytical skills with a keen attention to detail

Requirements:

• 3+ years of Manufacturing / cGMP experience
• Proficient as ERP system user [NetSuite preferred]
• Ability to lift materials and products up to 40 pounds
• Drive license is required
• May require the use of safety PPE or contamination control devices, including but not limited to eye safety glasses, lab coat, hearingprotectors, work boots