Production QA Specialist: Quality & Compliance

PhytogenX, Inc.; Morgantown (PA); On-site; USD 65,000 - 90,000; Full time

Job summary

PhytogenX, Inc. is seeking a Production Quality Assurance Coordinator to ensure all products meet quality standards by overseeing QA activities, monitoring manufacturing operations, and supporting continuous improvement initiatives.

You will partner with production, customer service, and quality teams to ensure GMP, GDP, and internal procedures compliance, maintain records, and drive CAPA and change controls.

Qualifications

• High School Diploma or GED required.
• Associate's or Bachelor's degree in Quality Management, Manufacturing, Life Sciences, or a related field preferred.
• Minimum of 2 years of experience in quality assurance, quality control, manufacturing, or a regulated production environment.
• Experience within FDA-regulated, GMP, or ISO-compliant environments preferred.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook).
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Experience with quality management software is a plus.
• Knowledge of GMP, GDP, CAPA, deviation management, change control processes, and quality systems preferred.

Responsibilities

• Review and approve fill specification sheets and ensure alignment with customer fill and assembly specifications.
• Photograph new production jobs to establish quality standards and production references.
• Organize, maintain, and update production quality standards utilized by Production QA personnel.
• Partner with Production QA leadership and production management to coordinate customer visits and ensure customer expectations are understood and met.
• Serve as a liaison between customer service and production teams regarding customer specifications, concerns, and quality-related issues.
• Report product quality concerns and compliance issues to Quality Management.
• Write, revise, and implement SOPs related to production quality activities.
• Verify production balances are functional, calibrated, and maintained in accordance with approved procedures.

Skills

Attention to detail

Written & verbal communication

MS Office

Quality systems

CAPA

GMP/GDP

Problem solving

Multi-project management

Education

Quality/Manufacturing/Life Sciences degree

Tools

MS Office

Job description

PhytogenX, Inc. is seeking a Production Quality Assurance Coordinator to ensure all products meet quality standards by overseeing QA activities, monitoring manufacturing operations, and supporting continuous improvement initiatives.

You will partner with production, customer service, and quality teams to ensure GMP, GDP, and internal procedures compliance, maintain records, and drive CAPA and change controls.