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The QA Specialist III supports quality compliance systems and objectives within the Chicago Heights, IL site. The incumbent maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This role interacts 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, cGXP, refresher and general training.
- Attend training to update personal skills and knowledge level.
- Proactively and continuously improves Zoetis’s internal processes and products with quality mindset.
- Manage, lead and report on FDA and regulatory compliance inspections. Assist with developing remediation efforts and FDA response when necessary.
- Manage and lead 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.
- Manage and lead 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.
- Keeps abreast of technological advances specific to industry and Quality Assurance. Updates and implements streamlining efforts and cost savings procedures. Develops new systems or procedures based on findings.
- 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 GMP/GLP/GCP regulations
- Keeps abreast of current GMPs and knowledgeable of current advances in the FDA and other regulatory agencies.
- Maintains Training records for the site
- Coordinates and investigates customer complaints
- 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 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.
- Ability to develop and communicate technical information with internal and external customers
- Support management on financial objectives, controls and department budget.
- May contact vendors and/or external customers for administrative and technical information.
- Serve as back-up to Quality Assurance Manager
EDUCATION AND EXPERIENCE:
- Qualified candidates will have a Bachelor’s degree in a scientific field.
- A minimum 10 years of scientific field preferably in a FDA regulated industry.
- Experience in Canadian, EMEA or Latin American regulated regions is desired. CQA certification desired.
TECHNICAL SKILLS REQUIREMENTS:
- Strong interpersonal and communication skills; ability to communicate across all levels of the organization.
- Excellent attention to detail and strong time management skills.
- PC literate with the following applications: MS Excel, Word, Power Point
- Ability to work independently and with work teams
- Strong technical writing skills
- Ability to manage multiple tasks and projects simultaneously
- Understands laboratory and manufacturing operations and scientific processes to enable system and documentation audits.
- Proven understanding and accomplishment in development and deployment of divisional quality systems associated training and roll out.
- Proven understanding of CAPA systems, training, and document control requirements. Ability to negotiate, troubleshoot, assess and remediate.
- Proven Ability to provide Quality guidance, recommendations, decisions, and feedback to the Analytical, Engineering, Manufacturing, Quality, and Regulatory teams. These are critical to the success of the business and to ensuring compliance and acceptable standards throughout all aspects of the company’s business practices. The impact of such guidance, decisions, and recommendations can have a direct effect on the company’s ability to develop new products and manufacture/produce existing products.
- Proven Ability to analyze and interpret data to utilize such data to make data driven decisions when providing guidance and recommendations. Provide guidance with respect to quality analysis and guidance for the decision making process associated with the contract manufacturers.
- Ability to prioritize work, goals and tasks per the divisional and corporate objectives.
- Ability to communicate within all areas of AHD to facilitate audits, trainings, compliance and support corporate objectives
- Ability to develop, conduct/direct and report audits, trainings, projects, and investigations in support of production, laboratory, contractors or other Zoetis groups.
- Availability for up to 20% domestic travel.