I retired from CSL Seqirus as of Jul 2023. However, I am open to part-time remote work. Let me help your team with my many years of creating, updating, reviewing and approving SOPs, Investigations, CAPAs etc. I am well versed in what Regulatory agencies are looking for in terms of finding Root Cause and developing effective CAPAs. I also have many years of experience working on the floor, and understanding the importance of writing clear, concise instructions for adult readers. My years working in QA allowed me to understand how to ensure documentation is audit ready. I also have years of experience working in QA for companies starting up new plants. (Hospira/Pfizer India and Shire/Takada in Social Circle Georgia).

As the QA Supervisor I provide day-to-day direction regarding QA oversight of production and ensure timely review of electronic batch records. I review and approve SOPs and provide SME guidance to investigators in order to identify root cause of deviations and suggestCAPAs that are sustainable and effective.I train all QA new hires and developed Qualification programs for batch review and batch release. I am often asked for guidance related to challenges during production and believe in a cooperative relationship with my Manufacturing counterparts. I have a passion for coaching others and draw on my years in various roles to bring examples and real life situations into the discussion. I strive to show others how rewarding this work can be over a lifetime.

Oversight of the Quality aspect of Propofol transfer to India green field site. Responsible for review of newly created SOPs and creation of batch records for this start-up site. Additionally I am accountable for the sending site Quality review and approval of all Validation and Engineering protocols. Specifically, I participate in creation of FMEAs to identify compliance and safety risks associated with production of the product at the receiving site and provide input to mitigate those risks. I co-author the batch records with the receiving site Manufacturing Science and Technology team to ensure thorough and concise instructions and provide input on record design to minimize operator documentation errors. In the US I review and approve all sending site protocols, summary reports, SOP revisions and Change Controls. Prior to the actual tech transfer I was the co-lead for the Compliance Remediation team, responsible for identifying all gaps as they related to agreement between USP, CFR, Corporate guidance and plant procedures. Our team was responsible for closing all identified gaps prior to FDA submission which we saw.to completion.Additionally I created the Manufacturing Quality training for on-the-floor review of documents and cGMP compliance. As well I created the Qualification protocol for Line Clearance and AQL inspection for the Vizag India MQ team.

Supervisor of a team Lead, and two specialists as we work together with Manufacturing to ensure accurate and timely documentation and cGMP compliance "on-the-floor"​ during formulation, aseptic filling, sterilization, visual inspection and packaging​.Partnered with Manufacturing, and Investigators to solve deviations and apply corrections, corrective actions and follow-up on effectiveness.In this role I was the first Supervisor of the newly created MQ department and as a result I created the training modules for the Manufacturing Quality area. During this time I was chosen to participate in two Corporate Cross-Functional "Mini-Teams". One team project was in the area of streamlining the deviation process from initiation to close of CAPA across all plants. The second was also a Lean project that included using the Clayton plant as the pilot plant for streamlining the batch review process. The objective of this team was to minimize operator documentation errors by providing a real time Quality presence in the Manufacturing areas.

In this position I supervised a team of exempt employees to ensure executed batch records were complete and accurate prior to release. As well I worked with the Investigations group to support closing deviations in a timely manner thus removing batch "restrictions"​. My experience in Production and MQ on-the-floor allowed me to assist in troubleshooting and creating CAPAs that addressed root cause.Additionally, I was utilized as the assistant to the MQ Manager. In this role I was responsible for the Quality review and approval of protocols, summary reports, change controls and SOP revisions. Assuring on-time closure of deviations, CAPAs and effectiveness checks was also my responsibility as well as providing weekly metrics such as batch review turn-around time, trending quantity of deviations caused by MQ, and batch "hold"​ times (restricted release due to deviations).In this role I was also used to as an investigator in order to eliminate a backlog of deviations. I was the investigator for two very high profile deviations; one for a CIP "spray ball"​ maintenance gap and a second for a glass defect investigation that involved previously release batches and put a large quantity of product on hold for re-inspection. Timely corrective action for this deviation was imperative and as a result I worked closely with Manufacturing and Batch Release to ensure proper handling of each batch. As a continuous improvement project I worked with the MQ "on-the floor" Supervisors and Leads along with the Batch Release team to identify opportunities to perform timely documentation review and eliminate dual effort that was non-value added. This project included creating a protocol to drive the change from current practice to the improved practice and used trending of errors identified, and their impact, to determine when each product line was ready to be moved to the new, improved process.

Coordinate and provide compliance oversight of 24 operators, formulators, filling techs and packaging personnel in the formulation, filling and packaging of small volume parenteral (SVP) injectables.Manage daily activities to meet customer supply needs Coach team to identify potential problems or compliance risks, and opportunities for improved efficiency.Update existing SOPs and create new SOPs. Participate in FAT for Serpa P-120 Cartoner and write subsequent operational and change-over SOPsIdentify exceptions to processes, work with investigators to drive to root cause and follow through with CAPA items Oversight of all personnel in regards to working safelyProvide mentoring to subordinates regarding the requirements of a regulated environment, without adding stress to our team effort.Assume the SME role for the SVP department during all audits.Back-up to the SVP department Manager in his absence.

Supervision of 13 operators in granulation, blending, compression, encapsulation, coating.Oversight of Manufacturing personnel and processes, ensuring compliance to cGMPs, SOPs and Safety requirements.Coordination of human resources with production requirements.Author and revise Standard Operating Procedures, Training Modules, and Training Assessments.Write and revise Master Batch Records, review of executed batch records.Initiation and investigation of deviation documentation including identification of root cause corrective/preventive action plans and follow-up.Assessment of training needs and follow-up on closing training gaps.Timely reporting to Head of Operations concerning schedule, maintenance needs, resolution of deviations and solutions to daily challenges.Work closely with QC and QA to ensure all manufacturing and packaging occurs within FDA and EU compliance.Write performance evaluation and conduct the appraisal meeting.Identify process improvements, research alternative supply vendors and purchase supplies.Assist Engineering and Validation Departments to support and assist in IQ, OQ, PQ and Validation activities.Assist Technical Transfer and Research and Development leader in Engineering Studies and R&D batches.Martec is a solid dose manufacturer of generic pharmaceuticals such a Itraconazole capsules and Nora tablets.

Brand Name Solid Dose, Liquids, Ointments; Production Department- Liquids, Creams, and Ointments such as Carafate Suspension, Silvadene Cream, and Nitrobid Ointment- 5 yrsExecute batch records, operation of CIP system, set-up of equipment as a pharmaceutical operator.Packaging Department- 9 yrsPackaging tech and set-up mechanic for combined 9 yrsSet-up, operation and troubleshooting of packaging equipment.Perform Preventive Maintenance on 9 machinesUtilize set-up reduction training (Single Minute Exchange of Die) to reduce change-over times.Identify and execute improvements to reduce downtime.Developed training modules for all package machinery.Trained all Team Members on Safety, Operation, and Monthly Preventive Maintenance for machinery.Trained new associates on Standard Operating Procedures within a controlled environment.Received Quality Awareness Award.After leaving this position to attend college, I was hired back as an Engineering Intern. During this time, I lead a project to passivate all lines used in the CIP system and manufacture areas of Liquids and Creams rooms.