Summary:
The position will monitor and support cGMP, FDA, EU, State and Federal regulatory compliance for third party manufacturers and key suppliers.
Responsibilities:
- Supplier Management (customer support, project management, timelines, track deliverables, etc.)
- Batch record review and approval
- Write and review Quality Agreements
- Perform, write and approve supplier assessments
- Initiate and perform change control assessments.
- Initiate, review, track, and close investigations (SIRs, LIs, CAPAs, and SCARs).
- Complete monthly and bi-annual quality metrics reports.
- Perform Annual Product Reviews to include collecting data, authoring reports, and drawing conclusions based upon the data collected on the continued validated state of the product.
- Review, write, and/or revise SOPs and specifications as required to ensure that procedures remain current
- Assist with cGMP training program and maintain electronic document management system.
- Manage and review customer complaint process (log complaints, investigations, and close complaints, communicate with third party partner, review and approve reports).
- Other duties may be assigned.
Qualifications & Requirements:
- Bachelor’s degree in a science related field.
- 3 years of experience in Quality Assurance or Quality Control in a government regulated environment.
- Travel up to 10% of time.
- Knowledge of 21CFR Part 11 (preferred, not required)
