Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.
Perform in-depth and thorough Device History Record (DHR) reviews and disposition all Abaxis/Zoetis products in compliance with established release procedures. Be alert to developing trends and proactively notify manager and Quality management of emerging issues.
Generate Certificates of Analysis and Certificates of Conformance for all Abaxis/Zoetis products.
Organize and maintain Device History Records.
Address issues with Device History Records (DHRs) in a timely manner
Demonstrate appropriate professional communication when interfacing with production personnel to resolve any documentation issues in DHRs.
Process ERP transactions to segregate and disposition non-conforming product.
Assist with developing, reviewing and improving procedures and processes related to product quality.
Assist with internal and external audits.
Other duties and responsibilities in the Quality Department as assigned
Education and Experience:
BS in Scientific discipline with relevant experience. Preferred three years of experience in an FDA regulated environment in the medical device industry and/or in-vitro diagnostics preferred.
Knowledge and experience with GMP and Good Documentation Practices required
Strong attention to details and ability to understand and follow complex procedures.
Strong technical skills including basic statistical analysis.
Sound working knowledge of regulations pertaining to QA and related compliance requirements.
Working knowledge and experience in basic computer applications such as Microsoft Word, Excel and Outlook. Experience in Visio is a plus
Effective and clear written and verbal communication skills.Full timeRegularColleagueZoetis 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 [Register to View] 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 [Register to View] 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.