Summary:
Position will monitor and maintain cGMP, FDA, State and Federal regulatory compliance procedures, provide cGMP training, and manage customer complaints to ensure compliance across all regulated processes.
Responsibilities:
- Change order/change control assessments for cGMP documents.
- Initiate, review, track, and close investigations (SIRs, LIs, CAPAs, and SCARs).
- Complete monthly and bi-annual quality metrics reports. Complete quarterly reports and year-end inventory for controlled substances.
- Perform Annual Product Reviews to include collecting data, authoring report, and drawing conclusions based upon the data collected on the continued validated state of the product.
- Review, write, and/or revise company SOPs as required to assure that procedures remain current
- Manage cGMP training program and electronic document management system.
- Manage customer complaint system. Log complaints, investigations, and close complaints, communicate with third party partner, review and approve reports.
- Review temperature and humidity reports for each stability chamber monthly and for the annual report. Review, sign off, and maintain the records of the QC water testing results.
- All other duties may be assigned.
Qualifications & Requirements:
- Bachelors Degree in a science related field.
- 3 years of experience in Quality Assurance or Quality Control in a government regulated environment.
