Bilingual Production Quality Assurance Coordinator in Morgantown, Pennsylvania at Phytogenx Incorporated

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.

In addition to production quality responsibilities, this role will be cross-trained in Quality Assurance Associate functions to provide support for the Quality department. The individual will assist with quality systems activities, regulatory compliance requirements, documentation review, investigations, and other quality-related responsibilities as needed.

Role and Responsibilities
Production Quality Assurance (Primary 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 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, non-conformances, 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.

Quality Assurance Support
• Cross-train 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, non-conformances, 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.

Experience, Qualifications and Education Requirements
• High School Diploma or GED required.
• Associate's or Bachelor's degree in Quality Management, Manufacturing, Life Sciences, or a related field preferred.
. Bilingual proficiency in English and Spanish (both written and verbal) is required
• 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.
• 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, investigation, and decision-making abilities.
• Ability to manage multiple projects and priorities simultaneously.
• Self-motivated with the ability to work independently and collaboratively.
• Knowledge of GMP, GDP, CAPA, deviation management, change control processes, and quality systems preferred.
• Reliable, dependable, and committed to maintaining high quality standards.

Physical Demands
• Ability to stand for extended periods and work within a fast-paced production environment.
• Exposure to production equipment, noise, dust, and manufacturing activities.
• Ability to work on a computer for extended periods.
• Ability to hear and understand spoken information in person and over the phone.
• Ability to read, analyze, and interpret technical documents, procedures, and quality records.
• Ability to occasionally lift and/or move objects up to 25 pounds.
• Ability to walk between office, laboratory, warehouse, and production environments as needed.
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PhytogenX is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, national origin, disability, veteran status, or any other protected status. Employment decisions are based on qualifications, merit, and business needs.