QA Compliance Specialist
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.Position SummaryThe Pharmaceutical QA Compliance Specialist – is accountable for ensuring cGMP compliance within the pharmaceutical manufacturing area and the evaluation and disposition of materials. Primary responsibilities include: Ensure materials released are compliant with registered specifications, review and release of pharmaceutical product, compliance to regulatory guidelines, quality oversight of the bulk and packaging pharmaceutical operations. This includes review / approval / implementation of new and revised Standard Operating Procedures, Batch Records, Process Validation protocols and reports, equipment qualification and change control, as well as ongoing QA support functions related to batch manufacturing and product release of FDA regulated pharmaceutical products The Pharmaceutical QA Compliance Specialist, will also interface directly with regulatory agency, customer and internal auditors, provide support for market action activities and will assist in the identification and communication site and department metrics. Position Responsibilities * Support all packaging and bulk production in Pharmaceutical Operations. * Monitor and enforce compliance to applicable regulations (FDA, DEA, EU, ect) * Accurately review Manufacturing and Packaging records to insure that the information and documentation conforms to Zoetis policy and cGMP”s and all other applicable regulatory guidelines * Serve as the primary reviewer and approver for batch records and change control documents. * Promptly perform and complete line clearances.
* Support QC laboratories and laboratory investigations. * Perform and maintain product release expectations and tasks necessary to ensure all regulatory and departmental documents are in compliance with regulations and company policies * Support others, when needed, to ensure all work is completed.
* Serve as the primary reviewer and approver for master batch records, SOPs and change control documents. * Provide support in review and approval of deviation investigations. * Maintain department related documentation * Accurately records each inspection or test result into the appropriate records. * Generates Certificate of Analysis (CofAs) and Laboratory Information System (LIMS) reports. * Escalate quality issues to management * Other areas of responsibility may include sampling and inspection of Bulk drug products & other tasks as requested. Education and ExperienceBachelors degreeJob level based on years of relevant experience:For the GJL 040-2 levelMinimum 0-2 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality OperationsFor the GJL 060-1 levelGreater than 2-4 years experience at an Associate Staff level position in Manufacturing or Quality Operations.PreferredMinimum 5 years progressive experience in the quality assurance, manufacturing, quality control or regulatory affairs function. Technical Skills and Competencies * Significant experience and understanding of pharmaceutical solid dose manufacturing, product transfer processes, process validation, equipment validation, cleaning validation * Significant experience and understanding of domestic and international regulatory requirements related to pharmaceutical manufacturing. Current knowledge of FDA/USDA/EU regulatory guidelines * Proficiency with QA release functions * Knowledge of Risk Management principals * Investigation and Problem Solving * Demonstrated ability to escalate issues * Ability to establish appropriate timelines to meet key milestones with some supervision * Functional knowledge of local, federal and international regulations * Knowledge of human error awareness / prevention * Organization skills * Verbal and written communication skills (fluent in English) * Works effectively in a team-based environment * Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines * Proficient in Microsoft Office applications * Attention to detail * Demonstrated ability to work with internal and external colleagues
Preferred Qualifications: * Demonstrated knowledge of the Deviation, Change Control, Document Management, ERP (SAP) and Laboratory Information Management (LIMS) systems. * Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs. Physical Position RequirementsLift materials up to 40lbsAbility to sit, stand and walkSome travel may be required