Quality Compliance Specialist

Company: Zoetis Spain SL
Location: San Diego
Posted on: November 26, 2022

Job Description:

400206The Quality Compliance Specialist supports the regulatory compliance and objectives within the QO department. - This individual works on regulatory submissions required for product release, outlines of production and regulatory change management.This position will interact with cross-functional groups such as Quality Control, Formulations, GMT, and Production. - He/ She will also interact with other Zoetis colleagues, outside of the San Diego site, as well as personnel of the regulatory agencies.POSITION RESPONSIBILITIES:

• Prepares and submits the regulatory documents and samples required for product release.
• Ensures any other necessary tasks related to product / release submissions required by quality operations are performed properly in a time manner.
• Manages the Outlines of Production team meetings and ensures effective communications with all the stakeholders. Coordinates and ensures the related activities are completed in a timely manner.
• Supports the regulatory submissions for diagnostics products as requested by Zoetis regulatory colleagues for international registrations. Provides documents for other compliance purposes as it is required by the business.
• Ensures the outlines of productions are revised and submitted to Zoetis regulatory colleagues for submissions.
• Creates the regulatory submissions (2020, 2008, outlines of production) that are necessary for product releases.
• Ensures that any other communications required to the regulatory agency, pertinent to product release is performed in a timely manner.
• Manages the release of finished products and all the QO related matters in SAP (ERP system).
• Initiates the regulatory change files in ETS to ensure a notification of change to the international markets with registered products.
• Supports the regulatory audits and the corrective actions required to address the audit observations.
• Ensures the availability of regulatory documents required for import or export of the products or components.
• Issues and files or communicates the COAs, COCs or other regulatory documents. -
• Ensures the review of batch records (in all levels of manufacturing) and proper filing of the batch records.
• Performs the compliance role in change management with the reviews and approvals required in the ETS system.
• Participates in all other QO functions as required by the QO department.EDUCATION/EXPERIENCE and TECHNICAL SKILLS REQUIREMENTS:
  • BS degree in a scientific field is required.
  • A minimum of 3-4 years related experience preferably in an FDA or USDA regulated industry.
  • Must have a good understanding of GMP and global regulatory standards.
  • Able to read, write, and speak English proficiently.
  • Ability to accomplish multiple tasks, projects, and duties.Full timeRegularColleagueAny 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.

Keywords: Zoetis Spain SL, San Diego , Quality Compliance Specialist, Other , San Diego, California