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This position supports quality compliance systems and objectives within the Chicago Heights, IL 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.
- 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 FDA response when necessary.
- Perform internal compliance, surveillance and focused audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report.
- Potential to perform vendor and supplier quality audits to assure quality of incoming materials and services as necessary.
- 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
- Supports the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions and lot deviations.
- Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.
- 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 as they relate to company products and procedures.
- Review, approve and verify accuracy of data on compliance projects.
- Maintains regulatory documentation supporting site processes and products, guidance documents, CFR, etc.
- Performs technical reviews and approves validation documents, design review, engineering reviews, IQ/OQ/PQ, quality support reports, protocols, final reports and miscellaneous 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.
- Support management on financial objectives, controls and department budget.
EDUCATION AND EXPERIENCE:
- BS degree in a scientific field is required.
- A minimum of 2 years related experience preferably in a 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 organization.
- May contact vendors and/or external customers for administrative and technical information.
- Excellent attention to detail and strong time management skills.
- PC literate with the following applications: MS Excel, Word, Power Point