Quality System Manager - Controlled Substances, Recall, and Notification to Management

Oversee a group of 28 people across 3 shifts to perform technical and product disposition review of batch records. Assess related investigations and change controls associated to a batch to give authorization for final QA release. Lead the QA shop floor team to spot check records, triage issues that arise in manufacturing, and perform daily coaching and mentoring of the operations team. Developed daily meetings with the team and shift notes to communicate relevant concerns from the previous day to upper management. Integrated base busineess as the process owner with the QSE team on the batch release process by developing SOPs and coordinating resources. Provided QA approval for the site stability program by reviewing study initiations, protocols, and final reports.Reduced cycle time of the batch record review by removing redundancies in the review process and consolidating the teams into one review. This resulted in a 40% efficiency in review time. QA liaison with the QC Analytical Lab by performing final QA approval on lab SOPs and provide insight and recommendations on lab investigations.

Oversee the batch release process which includes review of related investigations and change controls associated to a batch to give authorization for final release. Integrated base busineess as the process owner with the QSE team on the batch release process by developing SOPs and coordinating resources. Provided QA approval for the site stability program by reviewing study initiations, protocols, and final reports.QA liaison with the QC Analytical Lab by performing final QA approval on lab SOPs and provide insight and recommendations on lab investigations.

Consent Decree (CD) Site Lead for Stability. Managed individuals to ensure completion of site responsibilities on time. Create “as is” and “to be” process maps for the stability program. Identified Lancaster best practices to share with other sites. Prepared base business for integration of the new stability program. Helped to develop the statistical analysis approach for trending of stability data for QC release and APR/Annual reports.Reported teams progress monthly to CD management and determined infrastructure/resources needed to complete tasks on time. Developed and reported metrics to base business.

Managed the stability and retain program. Ensured collection of annual and change control stability samples by coordinating with planning, project owners and contract packagers. Performed statistical analysis of results to evaluate trending. Approved annual and APR reports for retain and stability. Drafted and updated SOPs for the stability and retain programs.Actively participated in change control meetings and provided input for all plant changes to ensure complete and accurate information. Determined stability requirements for each change. Instrumental in executing and approving quality investigations within the analytical lab. Created documents and organized data to present during compliance calls and escalation to management. Issued field alerts due to non-conformances. Supported FDA, MHRA, and internal auditors during inspections. Implemented responses for follow-up items to assure successful audits through the CAPA process.Performed data review for multiple testing techniques in the analytical lab: AA/ICP, HPLC, GC, FTIR, Wet Chemistry and others. Organized testing priorities for solids, liquids and raw materials in the lab. Created special test protocols and summarized findings to support manufacturing investigations. Served as the PE lean expert for the analytical lab. Organized and facilitated Kaizen events (Retain, Stability, Raw Material, Liquids Packaging Components, and Team Leader Standard Work). Reviewed test method validation protocols prior to execution and organized the corresponding testing within the analytical lab. Provided a summary report to the R&D team on the analytical lab testing results

Organized and performed supplier quality audits for raw material vendors and wrote up observations. Established an excellent working communication with vendors to ensure raw material quality. Reviewed and approved laboratory data in accordance with specification and regulatory documents. Trained lab analysts on SOPs and current GMP procedures. Wrote Reduced Testing protocols to eliminate testing in the QC lab which saved the site $900,000Responsible for ensuring a team meets raw material manufacturing time lines. Attend weekly meetings to communicate with manufacturing on laboratory progress. Filled in for the lab supervisor during vacations and absences.Assisted with hiring of new laboratory colleagues and their training.Led investigations within the chemistry lab on out of specification results and determine root cause.

Performed testing within the QC laboratory per GMP documents Created, updated, and provided training on SOPs in the Quality Department. Reviewed USP/EP for updates and ensured the lab complied with all new monographs.Worked with vendors to implement new equipment in the lab