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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.less thanbr> POSITION RESPONSIBILITIES:less thanbr> * Ensure approved quality systems are established and maintained.less thanbr> * Quality and compliance oversight of manufacturing and warehouse activities.less thanbr> * Helps prepare organization for FDA and other compliance audits.less thanbr> * Educate employees on quality system requirements and compliance expectations. Mentor employees to achieve compliance goals.less thanbr> * Develops training modules, provides new employee, cGMP, refresher and general training.less thanbr> * Attend training to update personal skills and knowledge level.less thanbr> * Proactively and continuously improves Zoetis internal processes and products with quality mindset.less thanbr> * Report on FDA and regulatory compliance inspections. Assist with developing remediation efforts and response, when necessary.less thanbr> * 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.less thanbr> * Work with personnel to facilitate and implement corrective and preventive action plans.less thanbr> * Maintains and/or monitors compliance tracking systems and archive records, e.g. document control, deviation reporting, calibration, records retention, records destruct, etc.less thanbr> * Understands and follows Pharmaceutical GMP regulations.less thanbr> * Coordinates and investigates customer complaints.less thanbr> * 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).less thanbr> * Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.less thanbr> * Coordinate and/or prepare periodic product review reports and MCSR documentation.less thanbr> * Work within Document Management and Learning Management Systems.less thanbr> * Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects.less thanbr> * Interpret and communicate existing and/or new regulatory requirements (e.g., 21 CFR Part 226) as they relate to company products, processes and procedures.less thanbr> * Prepare and/or verify data accuracy of supporting documentation for compliance submissions.less thanbr> * 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.less thanbr> * Provides compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation.less thanbr> * Develops supporting compliance documentation.less thanbr> * Uses creativity, innovation, teamwork and problem-solving skills to accomplish project tasks, meet budgetary requirements and timelines.less thanbr> * Ability to develop and communicate technical information with internal and external customers including regular weekly/monthly reporting activities.less thanbr> * Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support.less thanbr> EDUCATION AND EXPERIENCE:less thanbr> Level I:less thanbr> * BS degree in a scientific field is required.less thanbr> * A minimum of 2 years related experience preferably in an FDA regulated industry.less th

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