POSITION PURPOSE The Quality Assurance Technician interacts with the Analytical and Microbiology Technicians, Production, Warehouse, Compounding, Engineering, and Maintenance to facilitate the development and maintenance of quality systems.
ESSENTIAL FUNCTIONS AND BASIC DUTIES This position is responsible for assuring that products are being manufactured in conformance with established specifications and procedures and in accordance with regulatory requirements. The position also provides technical support for Operations leadership and Machine Operators in implementing Statistical Process Control and in maintaining a system of line / machine checks, inspection of incoming materials and finished goods, internal audits and in the completion of appropriate documentation. A key responsibility of this position is the identification of nonconforming products or processes, and leadership in continuous improvement efforts. • Daily inspection of all production lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP's). • Ensure that all manufacturing specifications are correct, clear and complete. • Audit cleanliness of machinery and operator's attire. • Sample and inspect in-process, finished products, returned and reworked material for quality. Determine final disposition on inspected products. Apply appropriate disposition label (via physical and virtual warehouse management systems) to material. • Accurately and completely document all inspection information on Daily Inspection Report (DIR). • Ensure raw materials are appropriately identified and released before use in production • Maintain computer data systems to reflect product release/quarantine status. • Ensure that all finished goods are identified and released according to cGMP's and Nice Pak SOP's and Work Instructions (WI's). • Support the development and use of Acceptable Quality Limits (AQL's), as well as train Operations leadership and Machine Operators on AQL and trouble-shooting techniques as required. • Facilitate the maintenance of documentation and tracking of nonconforming and rejected material. • Notifies and follow through with production and Quality when variations from procedures and specifications are observed. This function includes identifying non-conforming material, recording of it and distributing required documentation. • Collect samples as required by customers or Nice Pak's specifications. This includes any retain sampling as per manufacturing specifications and QC sample submission. • Support the communication with suppliers regarding quality issues, supplying samples and corrective actions. • Handle assignments as requested to establish and maintain product quality. • Perform any required testing as per SOPs and WI's. • Provide support to Production in all Quality efforts The above is intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.
PERFORMANCE MEASUREMENTS 1. Safety 2. First Pass Yield 3. Line Efficiency 4. Customer Service 5. Contributes to general continuous improvements
QUALIFICATIONS EDUCATION/CERTIFICATION: Bachelor's degree (science-related field preferred) or equivalent work experience
REQUIRED KNOWLEDGE: • Good knowledge of Quality Assurance systems and methods • Understanding of basic statistical concepts
EXPERIENCE REQUIRED: • Minimum of two years in an ISO-driven Quality Management System • 1-2 years of experience in manufacturing SKILLS/ABILITIES: • Proficient computer skills: Microsoft Office, BPCS • Excellent communication skills, both verbal and written WORKING CONDITIONS No hazardous or significantly unpleasant conditions.
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