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 documents.* Provide administrative support to the Quality Systems team.

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 ManufacturingOrganizations.* Facilitate the initiation, review, processing, approval, and closure of changes to productpackaging components in the TrackWise database.* Perform AQL inspection and release of printed packaging components for promotional use.* Active participant in prescription drug packaging serialization and unique deviceidentification (UDI) initiatives.* Perform Chemistry, Manufacturing and Controls (CMC) change control activities on an as-needed basis.

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 quality standards.* Created and implemented a filing system for training documents for better reference ofdocumentation.* Attained knowledge and experience in Business Planning and Control System (BPCS)Inventory Management and other computer applications related to departmental functions.; Set up and operated vial washes, dry heat ovens and autoclave sterilizers to manufacturingcycle specifications to support filling operations.* Cleaned and maintained processing rooms and equipment in a clean room environment.* Ensured batch records and other related documentation were current and accurate.* Assisted in the development of newer employees in the department. Became a qualifiedTrain the Trainer.; Inspect filled product for quality attributes such as gross container defects and particulates.* Qualified to inspect over 10 products produced at the facility.* Cross-trained to assist in the packaging department.