Quality Technician - Azer Scientific

MidAtlantic Employers' Association•Morgantown, PA

8d•Onsite

About The Position

Azer Scientific is hiring a full-time, on-site Quality Technician in Morgantown, Pennsylvania. The Quality Technician is responsible for quality control activities, monitoring production processes, handling nonconforming products, and implementing actions to ensure finished products meet quality standards, customer requirements, and regulations. The role reports to the Director of Quality and Regulatory Affairs and collaborates with cross-functional teams to identify improvement opportunities and drive continuous improvement initiatives. The position includes quality-control testing and inspections, managing nonconformance activities, maintaining quality documentation and traceability, and supporting calibration, product design, and employee training. The Quality Technician also manages the QC laboratory, including its consumables, equipment maintenance, and calibration.

Requirements

Technical school education or an equivalent associate degree; alternatively, technical education or a minimum of 5 years of cGMP work-environment experience.
At least 3 years of manufacturing or cGMP experience.
Proven experience in a QC or QA role, preferably in manufacturing, cGMP, production, or chemistry.
Proficient user of an ERP system.
Excellent written and verbal communication skills in English.
Familiarity with mathematics and statistical analysis tools and techniques for quality improvement.
Organized, proactive approach with the ability to prioritize tasks, work under pressure, and meet deadlines.
Ability to collaborate effectively with cross-functional teams.
Excellent problem-solving and analytical skills, with keen attention to detail.
MS Office skills.
Ability to lift materials and products up to 40 pounds.
Valid driver's license required.

Nice To Haves

NetSuite ERP experience preferred.
Knowledge of QMS standards such as ISO 9001 and/or ISO 13485, GMP, and FDA regulatory requirements.

Responsibilities

Perform QC testing, report results, and 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 inventory accuracy and lot traceability procedures.
Lead nonconforming product activities, internally and with vendors.
Initiate and lead actions to prevent nonconformities relating to products, processes, and the QMS.
Report quality and nonconformance data and trends to the Quality Manager.
Manage the QC laboratory, consumables, equipment maintenance, and calibration.
Support calibration of internal devices.
Process customer returns as needed.
Create, revise, and maintain quality documents as necessary.
Provide employees with training and guidance on quality-control processes, standards, and best practices.
Support the new product design process and discuss or update product specifications and raw materials as necessary.
Perform other duties as assigned.