Job Description Job Description
POSITION SUMMARY:
Under direct supervision of the Quality Systems & Regulator Compliance Department management, the Quality Assurance Auditor/Inspector is primarily responsible for auditing manufacturing operations and quality systems for compliance with Good Manufacturing Practices, Good Documentation Practices, and other company's established manufacturing operations and quality policies.
ESSENTIAL FUNCTIONS:
Responsibilities include but are not limited to:
• Enforce Current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs) at all stages of the manufacturing process and in all places within the manufacturing areas.
• Conduct routine "walk-through" in the manufacturing areas and other specified areas (such as restrooms, and break-rooms) to ensure that good housekeeping practices and good hygiene practices, which could affect the safety and quality of manufactured products, are followed.
• Verify that all raw materials and packaging components are properly received, stored and segregated (allergen vs. non-allergen; organic vs. non-organic, etc.) in the warehouse for raw materials and packaging components.
• Verify that processing equipment has been properly cleaned and sanitized in the staging/weighing rooms, compounding/batching rooms, powder blending rooms, filler and packaging rooms, etc.
• Audit the weighing/staging process to ensure that the correct raw materials are used and in correct amounts as specified in the Ingredients Batch Record.
• Audit the compounding/batching process to ensure that all raw materials allocated to the batch are indeed used and added to the batch in the sequence specified in the Manufacturing Instructions Batch Record.
• Collect in-process samples from the batch (as specified) and perform all required tests (pH, Brix, sensory evaluation, etc.) before releasing the batch for further processing (such as thermal
processing) and packaging.
• Collect samples of finished products (test samples, stability samples, and reserve samples), conduct specified testing and report testing results.
• Perform all applicable line clearance and inspections which may include measuring the product fill levels or fill weights, proper label application and cap torque, inkjet legibility on bottles and cases, and proper pallet configuration.
• Maintain all Quality and Production paperwork including bottle and cap tracking logs, shrink
sleeve tracking logs, area line clearances, room and equipment cleaning and sanitation, issuing of product specification sheets, etc.
• Verify that all quality control instruments (balances, pH, refractometers, thermometers, etc.) are properly calibrated and performing up to specifications.
• Sampling finished products for quality control laboratory, special testing such as stability studies, customer samples and maintaining reserve samples.
• Perform AQL inspections of finished product when rework is conducted or as directed by Quality Systems & Regulatory Compliance Department Management.
• Monitor the effectiveness of cleaning & sanitation (visual observation as well as using ATP bioluminescence method).
• Monitoring the concentration of sanitizers such as peracetic acid (PAA), QUAT and ozone as applicable to ensure that the levels do not exceed or fall below specifications.
• Assist in environmental monitoring (swabbing and air sampling) and pest control inspection.
• Perform other duties as determined by the Quality Systems & Regulatory Compliance Department Management.
REQUIRED EDUCATION / EXPERIENCE / SKILLS:
• Bachelor's degree in food science and technology, biology, microbiology or other related disciplines or equivalent work experience (High School Diploma with at least 3 years of work experience in related field or industry)
• Work experience in quality control/quality assurance operations in food, dietary supplement or pharmaceutical industry
• Experience with GMP regulations and Good Documentation Practices
• Sample collection experience is a plus.
Other Requirements:
Extended hours in a standing or walking position
May be required to regularly lift up to 25 pounds (lbs.) of materials
Must be able to accommodate varying start times based on production needs.
