Quality Assurance Specialist II

This position supports quality operations, 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. POSITION... RESPONSIBILITIES: • Provide in plant/on floor support and guidance for cGMP product quality assurance and compliance for Manufacturing Operations and warehouse activities. Supply manufacturing and packaging operations Quality oversight - supplying the WHY as well as the HOW Quality is applied. • Responsible for preparation and maintenance of the site Validation Master Plan in line with current requirements. • Ensure approved quality systems are established and maintained. • Identify and communicate potential compliance gaps / risks to management. • Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support. • Support and approve Manufacturing/Event Investigations and Corrective, Preventative Action (CAPA) and Laboratory Investigation records. • Educate and mentor site personnel on quality system requirements to achieve compliance goals. • Supports training management system and provides new employee, cGMP, refresher and general training. • Maintains and/or monitors compliance tracking systems and archive records, e.g., document control, deviation reporting, calibration, records retention, records destruct, etc. • Coordinates and investigates customer and supplier complaints. • Understands and follows Pharmaceutical GMP regulations. • Supports the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions and lot deviations. • Supports product release and inventory management activities. • Ensure that Product release is in compliance with the registration files. • Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc. • Assist in facilitation, organization, and reporting of site FDA and regulatory compliance inspections. Assist with developing remediation efforts and FDA response when necessary. • Uphold a state of constant inspection readiness at the site. • 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. • Provide support of the supplier management program including supplier audits and qualification of new suppliers. • Attend training to update personal skills and knowledge level. • Proactively and continuously improves Zoetis' internal processes and products with quality mindset. • 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. • Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process, dossier harmonization and working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues • 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. • Provide support with document control and learning management system functions. • Support the timeliness and effectiveness of the Site completion of Annual Product Reviews (APRs) through report compilation and review. • Assure the use of operational excellence tools in quality procedures and processes and Drive continuous improvement initiatives which positively impact process performance and product quality throughout the product lifecycle and provide assurance of continued suitability and capability of processes through Lean methodology and QRM Principles. • Through Key Quality Performance Indicator (KPI) Dashboard, monitor and report Site quality systems performance. • Provide support with site data integrity assessments and actions, as well as computer system validation (CSV) plans and execution. • Support mock recall activities for the site. • Management and oversight of the Food Safety Plan for the manufacturing site. • Other duties as assigned by Quality Management. EDUCATION AND EXPERIENCE: • Bachelor of Science in Biological sciences, Chemistry, Food Science or another related scientific field. • Minimum of 5 years progressive experience in the quality control, quality assurance, manufacturing function, or release roles supporting commercial registered product operations for animal health or human health products. • A minimum of 2 years related experience in an FDA regulated industry preferred. • Requires approximately 10% domestic travel. • Must possess strong oral and written communication skills and the ability to work independently. • Must have a strong understanding of GMP and global regulatory standards. • Demonstrated knowledge of compliance, quality and scientific principles in a Life Science environment is required. HACCP for Food Processors or FSPCA Preventive Controls for Human Food, are encouraged. • Demonstrated record of successful interaction with senior management, regulatory agencies (e.g. USDA, FDA) and other internal and external auditing groups. • CQA certification, Lean Six Sigma Qualification, PCQI desired. • Working knowledge of ICHQ10 key principles. • Success in maintaining Quality Systems and Standards at manufacturing site level. TECHNICAL SKILLS REQUIREMENTS: • Fluency in quality operations, systems and regulatory compliance. • Demonstrated written communication skills, as well as experience with presenting to leadership teams. • 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 • Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives. • Driven / Passionate about Quality performance and delivering results. • Fluent in English (written and spoken). • Demonstrated written communication skills, as well as experience with presenting to leadership teams. • Inspires Continuous Improvement and Breakthrough Thinking - utilizing problem solving tools such as Lean and Six Sigma PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly exposed to a laboratory, office and/or manufacturing setting. Incumbent must be able to access all areas of the facility and is required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety ("steel-toed") shoes, eye protection, gloves, and protective clothing. Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. 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 or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis