Amber Palkoner Email & Phone Number

Fishers, In, Us

Provide Quality oversight for Clinical Trial Dry Products Manufacturing and Packaging Operations

Senior Representative - Quality Assurance within the Clinical Trial Dry Manufacturing QA Development group. Primary responsibilities included:• Provided support for Clinical Trial Dry Products Manufacturing Operations • Approved API, comparators and finished dosage forms to be used in Clinical Trials. Involved review and approval of production and control records for cGMP compliance, maintaining batch records, and issuing Certificates of Analysis/Approval.• Approved/Released Clinical Trial Materials (Batch Disposition) per applicable regulatory commitments.

Responsible for 11 direct reports over 3 job functions (Quality Auditing, CAPA Administration and Quality Training). Responsible for all internal, client and regulatory inspections conducted at BPS. Served as lead inspection coordinator in mulitple regulatory inspections (FDA, MHRA, PMDA, ANVISA, Mexico MOH, Saudi Arabia MOH) and routine corporate assessments which involved audit preparation, audit execution, and corrective action follow-up. Served as Quality Management Representative by scheduling, organizing, and conducting quarterly management review meetings.

Supervised 6 Quality Auditors responsible for hosting client audits (approximately 40 per year) and conducting internal and supplier audits. Served as co-lead inspection coordinator during regulatory inspections.

Hosted client audits on a weekly basis. Served as lead and/or support auditor on internal or supplier audits. Provided support (scribe/document runner activities) to lead inspection coordinator during regulatory inspections.

Developed and executed cleaning validation protocols, analytical method validations, and recovery studies for client products. Also represented the Cleaning Validation department as project coordinator which involved client interaction, development of project plans, managing incoming and active projects, billing clients for completed projects, and reporting monthly scorecard to Senior Management.

Aseptically sampled and tested Water for Injection (WFI) for microbial, total organic carbon, conductivity, and endotoxin on a daily basis. Actively participated in process compressed air and nitrogen confirmations following annual facility shutdowns. Supported validation by performing orthophosphate and endotoxin testing.

Trended and summarized WFI results on a monthly basis. Supported cleaning validation by performing analytical method validation testing. Sampled and tested Softened Feed Water System and Reverse Osmosis water on a daily basis for hardness and chlorine content.