Process & GMP Manager - Medical

This position is responsible for leading the development and continual improvement of the both the medical production process and the execution of the GMP program in the Duncan SC Sealed Air Medical Applications facility.

* Manage the GMP Clerk.
* Tight partnership with Operations Manager and Training Coordinator.
* Responsible for developing and maintaining Standard Operating Conditions (SOC) for all commercial products.
* Responsible for developing and maintaining Standard Operating Procedures (SOP) for all production processes.
* Responsible for coordinating with corporate training in the development and maintenance of the Engineered Analytical Training (EAT) for all production processes.
* Leading and coordinating with R&D on all medical development and raw material replacement trial activities. Ensure that procedures supporting development trials are accurate and clearly documented.
* Lead process improvement projects for Duncan Medical facility.
* Collaboration with Operations on the Duncan Medical training program. Program to include training to SOP, SOC, EAT, GMP, and onboarding of new employees.
* Manage the PFS (Product Facility Safety) Program. This includes:
- Monthly PFS audits execution and communication
- Annual training and certification
- Coordinate mock recall
* Coordinating with Corporate Regulatory to maintain compliance for commercial product offerings and oversee any development regulatory needs.
* Responsible for maintaining the GMP training program to ensure compliance with quality systems and GMPs.
* Develop and implement metrics to measure the effectiveness of the GMP training program and implement modifications where necessary to maintain GMP compliance and competence.
* Prepare for and participate in external and internal audits.
* Maintain and update Special Plant Instructions (SPI) and Internal Manufacturing Specifications documents.
* Work closely with all other medical team members to ensure compliance with policies, procedures and customer expectations.

* BS Engineering degree
* Firm knowledge of extrusion processes preferred
* Firm knowledge of polymers experience preferred
* Knowledge of medical GMPs and/or regulatory preferred
* Experience in developing and implementing training content preferred