QA Compliance Analyst
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 on.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. 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.This position supports quality compliance and quality assurance systems and objectives at the Salisbury, MD site. Incumbent maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This will include the QC Laboratories which are located in Willow Island, WV supporting the Salisbury production site. This position will interact with cross-functional groups such as Quality Control, Regulatory Affairs and Production. The role will track and verify global dossier requirements and assure alignment with site processes and procedures, support CAPA and deviation program and provide additional site QA support. POSITION RESPONSIBILITIES:This job description reflects assignment of essential functions; it does not describe or restrict the tasks that may be assigned. * Ensure approved quality systems are established and maintained.
* Compliance oversight of quality, operation, and material storage activities. * Prepare organization for FDA and other compliance audits. * Assist the training monitoring and delivery of cGMP training of employees on quality system requirements and compliance expectations.
* Attend training to update personal skills and knowledge level. * Proactively and continuously improve Zoetis” internal processes and products with compliance mindset. * Report on FDA and regulatory compliance inspections. Assist with remediation efforts and preform tracking/monitoring of commitments associated with inspections. * Perform internal compliance, surveillance and focused audits. Maintain audit plan and conduct reviews of technical documentation, identify risks, determine actions and prepare final reports. * Work with personnel to perform root cause analyses and facilitate the implementation of 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/GLP regulations * Tracks and assists with customer complaint investigations and corrective actions. * Provide back-up support for 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.
* 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 assists in the preparation of 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: * A AS/BS degree in a scientific field is required. * A minimum of 2 years related experience preferably in a FDA regulated industry. * Requires approximately 5% domestic 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:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * 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, Trackwise, SAP Physical Requirements: While performing the duties of this job, incumbent must be able to access all areas of the facility. He/she will utilize certain Personal Protective Equipment, including but not limited to, hard hats, lab coats, safety (“steel-toed”) shoes, eye protection, gloves, and/or protective clothing.