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QA Specialist I (JR00006222)

Zoetis

Last Updated: 9/22/20

Job Description

This position supports quality compliance systems and objectives within the Eagle Grove, IA 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:

  • Ensure approved quality systems are established and maintained.
    • Quality and compliance oversight of manufacturing and warehouse activities.
    • Helps prepare organization for FDA and other compliance audits.
    • Educate employees on quality system requirements and compliance expectations. Mentor employees to achieve compliance goals.
    • Develops training modules, provides new employee, cGMP, refresher and general training.
    • Attend training to update personal skills and knowledge level.
  • Proactively and continuously improves Zoetis’ internal processes and products with quality mindset.
  • Report on FDA and regulatory compliance inspections. Assist with developing remediation efforts & response, when necessary.
  • Perform internal compliance (surveillance & focused) and supplier quality audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report.
  • Work with personnel to facilitate and implement 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 regulations.
  • Coordinates and investigates customer complaints.
  • Disposition of raw materials and/or finished goods based on technical record review (e.g., manufacturing batch records; packaging and labeling; test results; reprocessing instructions; regulatory status; deviations).
  • Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.
  • Coordinate and/or prepare periodic product review reports and MCSR documentation.
  • Work within Document Management and Learning Management Systems.
  • 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 (e.g., 21 CFR Part 226) as they relate to company products, processes and procedures.
    • Prepare and/or verify data accuracy of supporting documentation for compliance submissions.
  • Performs technical reviews and approves validation documents(e.g., IQ/OQ/PQ protocols and records of execution), quality support reports, and GMP related 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.
  • Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support.

EDUCATION AND EXPERIENCE:

Level I:

  • BS degree in a scientific field is required.
  • A minimum of 2 years related experience preferably in an FDA regulated industry.
  • Requires approximately 10% domestic travel and occasional international 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:

  • 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

Part time

Regular

Colleague

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 [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.



Company Details


Zoetis

Parsippany, New Jersey, United States

Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.