MQA Associate

Responsibilities

• Perform AQL (Acceptable Quality Limit) sampling during packaging of finished products according to defined sampling instructions.
• Conduct AQL testing by verifying pouch and strip appearance, weight, dimensions, print presence on strip and pouch, and seal integrity for each sample pulled.
• Accurately record and document results from each AQL test performed in accordance with cGMP and internal documentation standards.
• Communicate AQL alert, action, or failure limits promptly to Quality Assurance and Operations leadership.
• Segregate impacted product populations based on AQL testing results and clearly communicate criteria and instructions to Operations Supervisors and packaging operators.
• Carry out additional duties as assigned by QA Supervisors to support overall quality operations.
• Train and perform batch record review during production, ensuring completeness, accuracy, and compliance prior to release.
• Execute line clearance and control procedures to verify that equipment, materials, and documentation are properly changed over from batch to batch.
• Perform in-process control (IPC) testing and scale/balance verifications to support production quality.
• Monitor manufacturing operations to ensure adherence to quality policies and procedures, providing guidance and clarification to colleagues to maintain consistent product quality approaches.
• Initiate nonconformance records and coordinate resolution of quality issues by partnering with cross-functional teams, escalating issues to quality staff as needed for CAPAs and investigations.
• Author and review forms, batch records, work instructions, standard operating procedures, and protocols within an electronic document management system.
• Cover Environmental Monitoring program, including scheduling third-party water testing, performing sampling, and supporting report generation.
• Act as short- to medium-term (3–12 months) project owner for quality improvement projects aimed at enhancing efficiency or compliance.
• Understand the manufacturing schedule and provide timely quality support to ensure business continuity and smooth transitions between manufacturing stages.
• Operate with a strong sense of urgency in a fast-paced environment, making sound, ethical, and high-impact decisions related to product quality and batch disposition.
• Perform real-time review of operational records, including batch records, and assist in obtaining corrections or clarifications as needed.
• Issue and manage logbooks, ensuring proper documentation practices and traceability.
• Support lab-related activities as needed, including handling and delivery of samples and coordination with laboratory personnel.
• Demonstrate leadership on shift by raising issues promptly, supporting problem solving on the floor, and contributing to decisions regarding batch record releases and AQL-related concerns.
• Contribute to a culture of continuous improvement and compliance by participating in quality projects, process improvements, and team initiatives.
• Travel between nearby production facilities as required to support quality activities.
• Work flexible hours, including off-hour shifts and weekends, to support production and quality needs.

Qualifications

• High School Diploma
• Associate/Bachelor's Degree Preferred
• 2+ Years of Quality Testing Experience
• Experience with AQL Testing
• Experience with GMP