Helen Grigoriadis

Promoted to QAO Manager

• Review and approval of related records, support of deviations, investigations, CAPAs, and change controls, and monitoring and metrics for the API group.
• Participated in back-room audit support for CSL internal audit in January 2025 and assisted during tour with auditors for HLFGP audit. Working with various departments to get audit observations completed for HLFGP.
• Leads team to ensure all batch record reviews are completed and all associated items completed prior to shipping bulks to CMO. Work with colleagues in Marburg for Zemaira issues for batches sent there for filling.
• Have focused on coaching individuals. Currently coaching/mentoring one individual.
• Partner with manufacturing, operations and other groups as needed within the value stream regarding product quality aspects.
• Works closely with IOs to ensure IRAs, root cause and CAPAs are identified for deviations alone with helping investigating deviations.
• Completes JSOs per month.
• Work with Process Owners on Continuous Improvement.
• Provide QAO coverage to the other two Bulk Areas when requested or needed.

Senior QAO Specialist/QAO Support Owner March 2018-March 2023

Initially started as Sr. QAO Specialist for Utilities, Maintenance, Metrology and Facilities until 2021. In October 2021, I was promoted to QAO Support Owner. As a QAO Support Owner, oversight was provided for GMP Utilities.

• Review deviations for Utilities. Assist in investigating deviations and provide lead at times to complete deviations for Utilities and other areas.
• Assist in using root cause analysis tools to determine appropriate CAPAs.
• Initial approval of CAPAs. Provide final review to ensure CAPAs have been completed, and the proper effectiveness checks are completed.
• Review all facility HEPAs with collaboration from Utilities Management.
• Review and approve Out of Tolerances for entire facility.
• Lead and/or participate in area audits and GEMBAs.
• Assist in back room for audits
• Provide QA oversight on all issues as they arise.
• Ensure regulatory commitments are addressed and completed in a timely manner.
• Complete reviews of SOPs
• Complete and review metrics as required by Management.
• Assist other QAOs in the Parenteral and Manufacturing areas when need.
• Assist in quality review of pest control records.
• Assist in ensuring Preventive Maintenance and Calibrations are reviewed from quality perspective.
• Complete quality review on Change Controls.

As a QAO Specialist II in the Coagulation Department

completed batch record reviews, release of intermediates, investigated and wrote deviations.

• Reviewed paper batch records and batch records in MES.
• Investigated and wrote deviations with the assistance of the Group Lead and other QAO Specialists.
• Provided QAO coverage on the floor when needed.
• Released intermediates required for further processing of products.
• Attended risk assessments for change controls as needed.
• Revised SOPs for the Department.
• Completed internal audits of the area.

Aquestive Therapeutics (formerly MONOSOL RX), Portage IN November 2007-August 2013

Aquestive Therapeutics is a specialty pharmaceutical company leverage its proprietary PharmFilm® technology to deliver drugs in film

Senior QA Specialist August 2011-August 2013

As a Senor QA Specialist leadership was provided in support of deviations, release of raw materials, OOS and the CAPA Program and the Customer Complaint Program and ensured all quality-based deliverables were complaint with regulatory and procedures

• Prepared metrics for Senior Management Review.
• Maintained CAPA program for facility with Management providing oversight
• Review the release paperwork for final commercial product and raw materials.
• Reviewed OOS reports
• Conducted internal audits.
• Participated in FDA audits.
• Reviewed deviations.

QA Supervisor January 2009-August 2011

As a QA Supervisor leadership was provided and support to the Manufacturing Facility and Manufacturing QA

• Reviewed and approved GMP documents.
• Performed batch record review on the production floor.
• Ensured initiation of deviations were completed and assisted in investigations.
• Reviewed line clearances.
• Assisted in training of QA staff.
• Provided daily supervision of manufacturing QA staff and activities that covers multiple work shifts.
• AQL testing.
• Provided assistance for Quality issues on off hours.

QA Associate November 2007-January 2009

As a QA Associate provided support to the distribution of commercial product

• Issued batch records and labels to the QA on the floor in support of manufacturing.
• Performed final batch record review and disposition of final product.

Wolf Lake Terminals, Hammond IN June 2006-October 2007

Wolf Lake Terminals is a high-quality bulk storage facility.

Quality Control

As a quality control scientist, the main responsibilities were performing tests of stored liquids and performing biodiesel research experiments.

• Performed wet chemistry or analytical testing for solvents, surfactants and biodiesel per customer specification.
• Reviewed QC data and wrote Certificate of Analysis.
• Authored and reviewed SOPs.
• Maintained laboratory equipment.
• Dealt with customer inquiries on laboratory testing or inquires on the product stored at the facility.
• GC/MS research work on manufactured biodiesel.
• Participated in ISO audits.
• Conducted Internal audits.