Regulatory Affairs/Quality Assurance Specialist
- Oversee and manage inspection and quality control process and process control system; Provide advise to improve the current inspection and quality control process and process control system; Ensure and enforce quality control regulatory compliance.
- Plan internal audit process, conduct internal audit according related internal audit requirements and regulatory requirements; Report internal audit results accurately.
- Provide written reports of the internal audit to make sure all regulatory procedure followed.
- Test the effectiveness of revised qualify control procedure and quality control system after the audit; Maintain related audit documents.
- Assist second party, or third-party audit.
- Collects information and documentation to assist the audit
- Seek out related documentation as required or in response to agency requests.
- Update basic information provided to various departments regarding submission requirements and standards to facilitate efficient audit processing.
- Compiles and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure.
- Gathers regulatory submissions to be reviewed for compliance and audit submission standards.
- Tracks through audit review process to ensure timely submission.
- Some experience in QMS, audit and inspection preferred
- USDA/FDA experience preferred
- Must be flexible with schedule
- A Bachelor Degree or above in quality management, business administration, law and regulations, or a related field.
We offers full medical, dental/vision and life insurance coverage, good benefits and competitive salary. Please send resume and cover letter with salary requirement to: firstname.lastname@example.org
Hours of Work: 40 hours a week.(Full time) Work Location: Rancho Cucamonga CA