Quality Specialist I or II
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend.Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.This position supports quality compliance systems and objectives within the Willow Island, WV site. Incumbent 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, Regulatory Affairs and Production. 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, cGXP, 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. * 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/GDP/GCP 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, MSDS, 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. Support management on financial objectives, controls and department budget. EDUCATION AND EXPERIENCE:Level I: * 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.
Level II:In addition to Level I experience the following are required for a Level II: * A minimum of 5 years related experience preferably in a FDA regulated industry * Strong technical skills. * Experience in Canadian, EMEA or Latin American regulated regions desired. * CQA certification desired. * Demonstrated record of successful interaction with senior management, regulatory agencies (e.g. USDA, FDA) and other internal and external auditing groups.
* 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. * PC literate with the following applications: MS Excel, Word, Access