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Last Updated: 12/01/21

Job Description

This position supports quality compliance and quality assurance systems and objectives at the Willow Island, West Virginia site. Incumbent maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This will include the QC Laboratories located in Willow Island, WV supporting the Salisbury and Willow Island production sites. 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, Supplier Management, 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 compliance 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. Develop and implement Quality Road-maps for tracking compliance with corporate standards.
  • Assist with remediation efforts and perform tracking/monitoring of commitments associated with compliance inspections. Support regulatory agency inspections and conduct risk assessment of regulatory agency observations
  • Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis site quality assurance programs.
  • Perform internal/external compliance, surveillance, and focused audits of internal site operations, Suppliers and Contractors. Maintain audit plan and conduct reviews of technical documentation, identify risks, determine actions, and prepare final reports. Consolidating site audit data for tracking/trending for compliance communications to GMS and global quality compliance & auditing function.
  • Provides back-up support for maintenance 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 (GXP) regulations
  • Provide 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 for site quality systems and quality control.
  • 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.
    • Assure Site Regulatory Compliance to Registrations via the Regulatory Change Management process, dossier harmonization and execution of Lead Site Regulatory Role (Compliance Network Member), working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues.
    • Maintains the site Regulatory Change Management status, submissions, approvals program for Willow Island and provides support for Salisbury operations as needed. Maintain/coordinate QC related regulatory changes for Salisbury and Willow Island sites.
  • Provides compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation.
    • Develops supporting compliance documentation.
  • Ability to develop and communicate technical information with internal and external customers including regular weekly/monthly reporting activities.
  • Uses creativity, innovation, teamwork and problem-solving skills to accomplish project tasks, meet budgetary requirements and timelines.
  • 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 3 years related experience preferably in a FDA regulated industry.
  • Requires approximately 5% travel.
  • Must possess strong oral and written communication skills and the ability to work independently.
  • Must have an understanding of GXP 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, MS Word, 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.

Full 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

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.