JOB DESCRIPTION

The Quality Assurance Specialist is responsible for supporting the quality system processes and maintaining quality assurance standards, processes, and controls. This role involves close collaboration with Manufacturing, Quality Control, Maintenance, Shipping, and Receiving departments. The candidate must thrive in a fast-paced environment and be a self-starter. Although work primarily occurs during normal business hours, Monday to Friday, there may be instances where overtime or weekend work is necessary to support Manufacturing and Lot Release activities.

ESSENTIAL SKILLS

• Bachelor’s degree in a scientific discipline or equivalent experience.
• At least 2 years of experience in cGMP/FDA environment and ISO 9001 within relevant Quality Assurance/Compliance functions.
• Strong history in ISO 9001-2015, cGMP, CFR 210/211, FDA, Pharmaceutical, HACCP, Food Safety Management, and ICHQ7 requirements.
• Experience in a manufacturing environment, with a strong preference towards chemical manufacturing/processing.
• Knowledge of statistical process control (SPC).
• Strong project, time management, and conflict resolution skills.
• Exceptional written and verbal communication skills.

ADDITIONAL SKILLS & QUALIFICATIONS

• Training experience is a plus.
• Proficient with Microsoft Office tools, especially Excel.
• Experience with QT9 is a plus.

• Generate, review, facilitate corrections, and archive documents used to support Good Manufacturing Practice manufacture of Final Product.
• Perform internal and external audits as assigned.
• Review and release raw materials, intermediate products, and finished products. Assist in incoming material and tote inspection.
• Perform review and approval of Out of Specification (OOS), deviations, nonconformance, and investigations as required.
• Coordinate Corrective and Preventive Actions (CAPA), OOS, deviations, nonconformance, and investigations.
• Ensure systems comply with current Standard Operating Procedures (SOPs).
• Assist and perform investigations to resolve potential product quality issues.
• Assist with writing, revising, and approving standard operating procedures and work instructions.
• Review and approve SOPs, protocols, and reports as necessary.
• Coordinate and/or conduct Good Manufacturing Practice (GMP) training and SOP training.
• Generate, publish, and manage quality systems metrics to drive continuous improvement.
• Scan and archive GMP documents.
• Perform Quality Management System (QMS) related functions including calibration tracking, product release, etc.
• Assist Environmental and Safety as necessary.