The purpose of this position is to support Validation and Metrology programs with asset induction, regulatory asset management software data entry and administration, and work order scheduling. In addition, this position will support validation projects on an as needed basis at Argonaut Manufacturing Services. The position will report to the Manager of Validation. This is a high-demand, fast-paced work environment. We offer competitive salary, benefits, and equity participation.
- Coordinates calibration and validation activities with external vendors and internal stakeholders
- Responsible for maintaining equipment history files
- Responsible for regulatory asset management software data entry including asset induction and processing calibration and validation work orders
- Participate in vendor qualifications and supplier audits
- Support audits by customers and regulatory bodies
- Support execution of simple qualification activities
- Advise the manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for process improvements.
- Bachelor’s degree or high school diploma with equivalent experience required
- 1+ year(s) of experience in a regulated cGMP environment
- Detail oriented and strong written and verbal communication skills
- Knowledge of cGMP and GDP practices
- Ability to work under strict timelines
- Excellent problem solving / troubleshooting skills
- Strong initiative and willingness to take ownership and drive projects to completion
- Ability to work independently within prescribed guidelines and in a team-based environment
- Vendor scheduling and regulatory asset management system experience, preferred.