Quality Department

Regulatory Affairs/Quality Assurance Specialist

Primary Responsibilities:

  1. 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.
  2. Plan internal audit process, conduct internal audit according related internal audit requirements and regulatory requirements; Report internal audit results accurately.
  3. Provide written reports of the internal audit to make sure all regulatory procedure followed.
  4. Test the effectiveness of revised qualify control procedure and quality control system after the audit; Maintain related audit documents.
  5. 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.

Requirements:

  • 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: wangjun@ccicna.com 

Hours of Work: 40 hours a week.(Full time)  Work Location: Rancho Cucamonga CA