The Quality Systems Engineer, a member of Quality Operations (QO) team, supports the quality compliance standards and objectives within the QO department. This individual maintains a quality mindset and implements continuous improvement efforts and quality initiatives as per the Site’s requirements pertinent to the Zoetis Quality Standards (ZQS), USDA regulatory requirements and ISO 9001 Quality Standards.
This position will interact with cross-functional groups such as Site Operations, Quality Control, Formulations, R&D and Production. He/she will also interact with the Zoetis audit team, regulatory agencies and other internal colleagues as necessary.
- Supports the development and maintenance of the internal audit plans and prioritizes site audits. Performs the SD site internal audits and ensures the communications and follow up actions with departments.
- Assists with facilitating external site audits including the USDA and other regulatory bodies, corporate audit team, ISO, and Customers.
- Ensure that corrective and preventive actions related to all audits are identified with their corresponding completion timelines. Assists with developing the remediation efforts and responses when necessary and supports with the audit report writing.
- Support the supplier’s management program for quality operations, in collaboration with the corporate audit team. Ensures on time audits of suppliers and proper documentation of the suppliers’ qualifications and audits.
- Works with operations to develop training modules for departmental roles. Works with the Zoetis learning central team to ensure site alignment and proper execution of Zoetis principles at the San Diego site.
- Integrate corporate level procedure at site level and train site accordingly. Develop or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, MSDS, etc.
- Support in product release processes including initiating the product release in SAP, batch records review and filing, QA release of finished goods for distribution.
- Complies quality metrics for monthly quality councils and annual management reviews.
- Participates in all other QO functions as required by the QO department and defined by the Site Quality Leader.
Education and Experience
- BS degree in a scientific field is required.
- A 2-5 years related experience preferably in a USDA or FDA regulated industry.
- Must possess strong oral and written communication skills and the ability to work independently.
- Must have experiences with the Internal and External Audits.
- Must have a good understanding of regulatory standards.
- Able to read, write, and speak English proficiently.
- Ability to accomplish multiple tasks, projects, and duties.
Technical Skills and Competencies
- Ability to effectively review in-process and product final testing to ensure compliance with requirements.
- Ability to effectively identify additional testing requirements and analyze results when product testing does not fall within required limits or when other information calls in to question a products adequacy for use.
- Ability to effectively organize process audits to insure a high level of compliance.
- Strong computer skills including Outlook, PowerPoint, Excel, Word.
- SAP, Veeva Vault, and ETS experience a plus. Previous LIMS implementation a plus.
Physical Position Requirements
- Occasional lifting up to 30 pounds.
- Frequent bending, walking and stopping within a manufacturing environment. Significant computer usage requirements.
- Some travel may be required for Supplier Audits.