Production Quality Assurance Coordinator

The Production Quality Assurance Coordinator is primarily responsible for ensuring that all products meet PhytogenX quality standards by overseeing production quality activities, monitoring manufacturing operations, implementing quality assurance measures, and supporting continuous improvement initiatives. This position serves as the primary quality resource for production operations and works closely with production, customer service, and quality teams to ensure compliance with customer requirements, GMP standards, and internal procedures.

• 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 Standard Operating Procedures (SOPs) related to production quality activities.
• Verify production balances are functional, calibrated, and maintained in accordance with approved procedures.
• Maintain detailed records of inspections, deviations, nonconformances, corrective actions, and rework activities.
• Monitor production processes to identify quality concerns and opportunities for improvement.
• Enforce health, safety, environmental, GMP, GDP, and hygiene standards within production operations.
• Facilitate quality training sessions for production personnel on procedures, expectations, and best practices.
• Collaborate with operations and quality teams to drive continuous quality improvement initiatives.

• Crosstrain in Quality Assurance Associate responsibilities to provide departmental support and ensure continuity of quality operations.
• Maintain a working knowledge of quality systems, regulatory requirements, FDA expectations, and ISO 22716 standards.
• Assist in maintaining cGMP compliance and promoting quality awareness throughout the organization.
• Support and reinforce Good Documentation Practices (GDP).
• Review and track batch records for completeness and compliance.
• Generate and review Certificates of Analysis (CoAs).
• Assist with authoring, reviewing, and maintaining validation documentation.
• Support Annual Product Reviews (APRs) and other quality system activities.
• Monitor the timely completion of CAPAs, deviations, nonconformances, investigations, and change controls.
• Assist with customer complaint investigations and quality related documentation.
• Support the review, revision, and implementation of SOPs as needed.
• Conduct training sessions and presentations related to quality programs and procedures.
• Provide flexible support across Quality functions to meet departmental needs and business objectives.

• 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 with in FDA regulated, GMP, or ISO compliant environments preferred.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook).
• Experience with quality management software is a plus.
• Strong problem solving,…