Skye Higgins Email & Phone Number

Support and maintain Quality Systems documentation.* Monitor and maintain the Quality Complaints and CAPA systems.* Facilitate the routing and approval of documents and the distribution of controlled copies.* Write and revise standard operating procedures, work instructions, and controlled forms.* Ensures the accuracy, availability, and security of all.

Responsible for coordinating all changes to commercial product packaging components.* Work closely with Regulatory Affairs, Technical Services, Legal, Graphic Artists, andMarketing to understand the functionality of products to meet product labeling andpackaging requirements.* Cross-functional liaison between internal stakeholders and external Contract.

Responsible for coordinating customer complaints and samples.* Receive and log incoming quality complaints into TrackWise database.* Investigate quality complaints for defects and document inspection results.* Coordinate lot and sample investigations with contract manufacturers.* Generate weekly open item reports in TrackWise.

Perform sampling, inspection, line clearance, testing, record review, and area audits to ensurecurrent Good Manufacturing Practices (cGMP) compliance in manufacturing operations.* Performed interdepartmental audits of procedures and processes.* Reviewed Batch Record documentation, ensuring procedural and GMP compliance* Wrote and revised SOPs to maintain.