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ZOETIS US LLC QA Specialist I in EAGLE GROVE, Iowa

This position supports quality compliance systems and objectives within the Eagle Grove, IA site. The candidate maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This position will interact with cross-functional groups such as Quality Control, Production, and Regulatory Affairs. POSITION RESPONSIBILITIES: * Ensure approved quality systems are established and maintained. * Quality and compliance oversight of manufacturing and warehouse activities. * Helps prepare organization for FDA and other compliance audits. * Educate employees on quality system requirements and compliance expectations. Mentor employees to achieve compliance goals. * Develops training modules, provides new employee, cGMP, refresher and general training. * Attend training to update personal skills and knowledge level. * Proactively and continuously improves Zoetis internal processes and products with quality mindset. * Report on FDA and regulatory compliance inspections. Assist with developing remediation efforts and response, when necessary. * Perform internal compliance (surveillance and focused) and supplier quality audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report. * Work with personnel to facilitate and implement corrective and preventive action plans. * Maintains and/or monitors compliance tracking systems and archive records, e.g. document control, deviation reporting, calibration, records retention, records destruct, etc. * Understands and follows Pharmaceutical GMP regulations. * Coordinates and investigates customer complaints. * Disposition of raw materials and/or finished goods based on technical record review (e.g., manufacturing batch records; packaging and labeling; test results; reprocessing instructions; regulatory status; deviations). * Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc. * Coordinate and/or prepare periodic product review reports and MCSR documentation. * Work within Document Management and Learning Management Systems. * Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects. * Interpret and communicate existing and/or new regulatory requirements (e.g., 21 CFR Part 226) as they relate to company products, processes and procedures. * Prepare and/or verify data accuracy of supporting documentation for compliance submissions. * Performs technical reviews and approves validation documents(e.g., IQ/OQ/PQ protocols and records of execution), quality support reports, and GMP related project documentation. * Provides compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation. * Develops supporting compliance documentation. * Uses creativity, innovation, teamwork and problem-solving skills to accomplish project tasks, meet budgetary requirements and timelines. * Ability to develop and communicate technical information with internal and external customers including regular weekly/monthly reporting activities. * Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support. EDUCATION AND EXPERIENCE: Level I: * BS degree in a scientific field is required. * A minimum of 2 years related experience preferably in an FDA regulated industry. * Requires approximately 10% domestic travel and occasional international travel. * Must possess strong oral and written communication skills and the ability to work independently. * Must have an understanding of GMP and global regulatory standards. TECHNICAL SKILLS REQUIREMENTS: * Strong interpersonal and communication skills; ability to communicate across all levels of the

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