Quality Coordinator

ALS Therapy Development Institute; Abilene (TX); On-site; USD 50,000 - 70,000; Full time

Job summary

ALS Therapy Development Institute in Abilene, Texas, is seeking a Quality Coordinator to manage quality systems and ensure compliance with standards. You will oversee quality data, coordinate team activities, and perform audits to drive continuous improvement in quality processes.

The ideal candidate has a BA/BS or AA/AS degree and two years of relevant experience. Strong leadership and analytical skills are essential. Join a dynamic team dedicated to maintaining high quality and compliance standards.

Qualifications

• Two years of experience in a quality role in a manufacturing environment.
• Experience with internal and external quality audits.
• Ability to support and develop inspection methods.

Responsibilities

• Manage document control and monitor quality checks.
• Coordinate with techs for daily quality activities.
• Conduct quality audits and manage inspection processes.

Skills

Quality Audit Experience

Root Cause Analysis

Leadership

Document Control

Continuous Improvement Tools

Education

Relevant BA/BS or AA/AS degree

Tools

Microsoft Office

Quality Management Software

Job description

The Quality Coordinator works with the team to ensure the quality systems are realized and are in place at Next Level. The duties include (but are not limited to): daily collection/evaluation of quality data, monitoring and reporting of Key Performance Indicators (KPIs), support of in-process and incoming inspections, and development of new inspections and test methods. Train team members on measurement methods, support Product Engineering Projects, and internal and external audits. The position requires strong leadership to help drive, improve, and enforce quality standards. The responsibilities of this position will change as the organization grows. This position requires that an individual be able to lift up to 50 pounds, be willing to work as part of a team, be able to work alone, think quickly, and follow directions.

Primary Functions

• 40% Internal Systems: Audits, Calibration, Document Control, Non-Conformance, System Review, Process Capability
• 20% Coordinating Daily Activities for Techs and Supporting Training / Continuous Improvement Activities
• 20% Quality Data: Collection, Analysis, Risk Assessments, RCA, and Collection Improvements
• 10% External Systems: Audits, Suppliers, and Customer Data
• 10% Other Duties as Assigned

Job Responsibilities

• Responsible for the day-to-day activities for the document control process, lab TOA testing, and line quality checks
• Support internal aspects of Non conformance management. Collect data associated with investigation, root cause, and corrective actions. Works with Management or QPE to find resolution
• Ensure the calibration system complies with customer and plant requirements, One Point Lessons are effective and cover all processes required within the Quality System
• Support Engineering teams in developing, testing, and implementing process improvements, monitor and support 5S and E.D.G.E. (Every Day Great Execution) activities for/in production and quality
• Develops and coordinates the daily activities of the quality techs. Ensure audits are completed (internal, external, results review), and manages incoming inspection and testing (AQL GII 0.65 Critical, 2.5 Major, 4.0 Minor, FTIR, COA, Sensory, Micros, etc.), 5S, and all Quality Tech responsibilities (quality checks, reports, paperwork, RCA & CAPAs)
• Accomplishes QA objectives by facilitating the training of the quality team on the appropriate process of quality inspections
• Coordinate the techs to complete their work. Review the results and report them to Production and Quality staff as needed
• Supervision and performance management of quality techs (utilization, performance, discipline, calibration, development)
• Achieves Key Performance Indicator (KPI) objectives by helping develop the appropriate production/quality data collection processes, collecting the data (including nonconformance), and conducting the appropriate analysis and report results as assigned digitally and via Visual Boards (Site Boards, QA Details Report, Hold Slicer, Complaint Slicer, FS Culture PPT)
• Attend Production, Quality, & Food Safety meetings, this includes owning a project or being a part of a team that implements Corrective or Preventative action to ensure the KPIs are met and Food Safety systems and programs are compliant
• Review of shop packets, HACCP / Preventive control checks, quality checks, & reporting for discrepancies or inaccurate data
• Monitor and report on check & test results (trends, Top 5 Downtime, Top 5 Holds, Complaint Reduction Plan). Helps support the development of in-process test methods as needed
• Support for internal and external SQF, FDA, USDA, GFCO, and ESG Audits. Support third-party and customer audits
• Assist with the implementation and verification of corrective action required from various audits
• Responsible for ensuring that "right first time" Quality is always a priority and that quality is never compromised
• Other duties as assigned by management

Knowledge/Competencies

• This position requires a relevant BA/BS or AA/AS degree, and two years' experience working in Quality in a manufacturing environment, or an equivalent combination of education, training, and experience.
• Must understand and be able to support the development of inspection methods and drawings
• Knowledge of Root Cause and Corrective Actions
• Ability to lead and motivate a team and to positively influence others
• Experience with Quality Audits (internal and external)
• Working knowledge of continuous improvement and problem-solving tools
• Must have a valid driver's license and reliable transportation
• Must complete record check and drug screening prior to employment
• Must be legally eligible to work in the United States without sponsorship
• Formal training in areas such as Food Safety, Food Defense, HACCP, GFCO, Hygiene, GMP, Coding, Labeling etc. preferred
• Must be able to write clearly and informatively, and be able to read and interpret written information
• Troubleshooting capacity, process controls, able to ask questions and investigate to find root cause
• Basic Microsoft Office and database application skills. Position has development opportunities Level 1,2,3 if applicable

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice