Quality Assurance Analyst D Shift

Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE This role, recognized as a safety-sensitive position, plays a pivotal role in ensuring product quality, regulatory compliance, and the continuous improvement of quality systems. The Quality Assurance Analyst collaborates closely with Analytical and Microbiology Technicians, Production, Warehouse, Compounding, Engineering, and Maintenance teams to achieve these objectives. The primary responsibilities of this position encompass: Quality Assurance: Assuring the compliance of incoming raw materials and finished products with established specifications, procedures, and regulatory requirements. Product Compliance: Overseeing that all products under production adhere to the predefined specifications, procedures, and regulatory standards. Project Support: Providing essential support for trials and other projects when needed. ESSENTIAL KSA'S (KNOWLEDGE, SKILLSET AND ABILITIES) This position is responsible for assuring that the materials being used, and products being manufactured are in conformance with established specifications, procedures and in accordance with regulatory requirements. The position also provides technical support for Operations leadership and Machine Operators by maintaining a system of line / machine checks, 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. Additionally, this position will be responsible for the accurate analysis of incoming raw materials, bulk liquids and finished products utilizing Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak's Test Methods (NPTMs), Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). Assures released raw materials, bulk liquids and finished products have met the required specification criteria prior to release. Maintain accurate, complete, and traceable documentation related to analysis and disposition. Review documentation to ensure adherence to internal and external requirements. Production Line Inspections: Conduct daily inspections of all production lines to uphold Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs). Verify operator execution of routine quality inspections as required on Daily Inspection Reports (DIRs). Perform Audits: Audit machinery cleanliness GMP GDP Internal Audit Program Finished Product Sampling/Testing/Dispositioning: Sample, inspect, and test in-process, finished products, returned items, and reworked materials for quality. Determine the final disposition of inspected products and apply appropriate disposition labels in both physical and virtual warehouse management systems. Maintain computer data systems to reflect product release/quarantine status. Verify that all finished goods are identified and released in accordance with cGMPs, Nice Pak SOPs, and Work Instructions (WIs). Proficiently handle customer complaint retain pulls, inspections, data collection, and documentation. Raw Material Handling: Ensure that raw materials are properly identified, tested, and released before use in production. Maintain accurate, complete, and traceable documentation of raw materials. Perform physical and graphics inspections of raw material samples as needed to support operations. Nonconformance Management: Facilitate the maintenance of documentation and tracking of nonconforming and rejected materials. Notify and collaborate with production and Quality when variations from procedures and specifications are observed. Proficiently manage the non-conformance process, documentation, and Master Control routing. Sample Collection: Collect samples as required by customers or Nice Pak's specifications, including any retain sampling. Provide samples for analytical and/or microbiological testing as needed. Quality Support: Provide support to Production in all quality efforts. Perform any required testing as per SOPs and WIs. Complete investigations and Corrective and Preventive Actions (CAPA) issued to QA. Create and revise procedures and Visual Management System (VMS) documents through completion. Create and maintain Visual Quality Standards throughout the operational process. Location Audits: Perform QA location audits and reconciliations. Perform Analytical Testing Performance of required Analytical, Chemical, and raw material testing according to NPTMs, SOPs and WIs on raw materials, bulk liquids, and finished products. Ensure that all results are accurately recorded in appropriate laboratory notebooks and another designated forms according to GLP's. Prepare solutions and titrants when required. Clean and sanitize laboratory at specified intervals by following appropriate SOP and/or WI. Coordinate release of liquid batches including designation of re-assay/expiration date. Determine product's disposition. Complete necessary forms and distribute to appropriate parties. Documentation Management: Conduct routine inspections of Job Jackets to ensure completeness and compliance with Good Documentation Practices (GDP). Maintain and organize all hard copies of specifications and master files. Manage the Document Control System, including filing, routing, revising, distribution, and retrieval of documents. Revise, write, and route Work Instructions, Standard Operating Procedures (SOPs), and Forms. Ensure up-to-date and controlled documents are readily available on production lines. Maintain the Master list and Master Electronic files. Quality Coaching: Provide coaching on Good Manufacturing Practices (GMP) and GDP to operators. Rework Documentation: Generate documentation for rework processes and ensure that operations and warehouse personnel understand the rework requirements. Reconcile reworked material in the Warehouse Management System (WMS) and update appropriate documentation. Customer Complaints: Lead the investigation process and responses for all customer complaints, which includes retaining sample pulls, inspections, data collection, and updating the documentation in the system. Continuous Improvement: Assist in Nice Pak's continuous improvement efforts to enhance quality systems and processes. Administrative Duties: Perform all other duties as assigned. 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 Safety Compliance and Incident Prevention: Monitor and maintain a safe work environment by adhering to safety protocols, procedures, and regulations. Proactively identify potential safety hazards and non-compliance issues. Report and address safety incidents and near-miss occurrences promptly. Collaborate with the safety team to implement safety improvement initiatives. Participate in safety initiatives and contribute to a safety culture within the organization. First Pass Yield: Achieve First Pass Yield Goal Rework Reduction: The number of rework instances and defects related to inspected products. Productivity Improvement: Contributions to improving first pass yield over time. Root Cause Analysis: The thoroughness and effectiveness of root cause analyses for non-conforming products. Line Efficiency: Reduction in unscheduled line downtime due to quality issues. Machine Maintenance Support: Contribution to the maintenance of machinery and equipment for optimal line efficiency. OEE (Overall Equipment Efficiency): Monitoring and helping to improve OEE to maximize production efficiency. Continuous Process Improvement: Initiatives taken to enhance line efficiency and meet FPY and FTR goals. Customer Service: Timeliness of resolving customer complaints and issues. Responsiveness to customer inquiries and concerns. Contributes to General Continuous Improvements: Participation in Improvement Projects: Engagement in cross-functional teams and continuous improvement projects. Waste Reduction: Contributions to reducing waste and optimizing resource utilization. Process Efficiency Enhancement: Initiatives aimed at streamlining processes and increasing overall efficiency. Training and Knowledge Sharing: Active involvement in training and knowledge sharing to drive continuous improvement initiatives. Quality Compliance and Documentation: Adherence to established quality standards, procedures, and regulatory requirements. Accuracy in documentation, testing, and inspection processes. Timeliness and effectiveness in addressing deviations, non-conformances, and safety incidents. Rate of successful problem resolution and improvement initiatives. Participation in training and knowledge sharing for process enhancement. Compliance with established quality standards throughout the operational process. QUALIFICATIONS EDUCATION/CERTIFICATION: Bachelor's degree Preferred REQUIRED KNOWLEDGE: See Skills and Abilities section Below EXPERIENCE REQUIRED: 1-2 years of experience in manufacturing preferred SKILLS/ABILITIES: Technical Skills: Quality Control: Proficiency in quality control processes, including inspection, testing, and auditing to ensure products meet quality standards. Regulatory Knowledge: Understanding of industry-specific regulations and standards (e.g., FDA, ISO) related to product quality and safety. Documentation: Strong skills in maintaining accurate and comprehensive records, including document routing and filing. Testing and Inspection: Competence in conducting various types of testing and inspections on products, materials, and processes. Statistical Analysis: Ability to apply statistical techniques for data analysis and process improvement. Data Management: Proficiency in data entry, analysis, and reporting using computer software and data management systems. Technical Writing: Capability to create, update, and revise standard operating procedures, work instructions, and quality manuals. Computer Proficiency: Competency in using software applications such as Microsoft Office, database systems, and quality management software. Abilities: Attention to Detail: A keen eye for detail to spot deviations, defects, and discrepancies in products and processes. Problem-Solving: The ability to identify issues, analyze root causes, and implement corrective and preventive actions. Communication: Effective written and verbal communication skills for conveying quality-related information and collaborating with colleagues and other departments. Teamwork: The capability to work collaboratively within cross-functional teams and provide support to machine operators and other quality staff. Critical Thinking: The capacity to analyze information, make informed decisions, and prioritize tasks effectively. Time Management: Strong organizational skills to manage multiple tasks, meet deadlines, and adapt to changing priorities. Safety Awareness: A commitment to following safety protocols and maintaining a safe work environment. Customer Focus: Understanding the importance of meeting customer expectations and resolving customer complaints effectively. Continuous Improvement: A mindset for seeking opportunities to enhance processes and product quality. Audit and Inspection: Capability to perform internal audits, inspections, and checks for compliance. Conflict Resolution: Skill in addressing conflicts and issues related to product quality and procedures. WORKING CONDITIONS NONE: No hazardous or significantly unpleasant conditions. #LI-DC1