Michaela Walsh Email & Phone Number

Cambridge, Massachusetts, United States

Pharmaceutical Manufacturing site specializing in viral vector services; manufactures for a variety of different clients. Worked cross functionally to determine CAPA plans, owned CAPAs to closure and ensured due dates were met. Revised technical documents per CAPAs, Change Controls, Periodic Reviews, and Practical Process Improvements.-Met with deviation investigators and SMEs to develop effective CAPA plans for deviations that addressed the root cause. Drafted proposal plan and presented to a CAPA review board consisting of area management and quality. -Opened 4+ CAPAs per week in the Trackwise System, assigned actions and due dates appropriately.Owned and managed 20+ CAPAs at a time ensuring all actions closed on time.-Met weekly with management to give updates on CAPAs, escalating issues when necessary.-Ran queries in the Trackwise System to monitor CAPA effectiveness and complete effectiveness checks.-Communicated cross functionally with manufacturing SMEs, management and quality to revise and create technical documents (SOPs, WIs, Forms, Job Aids, Batch Records, etc.) for many clients in the -Documentum EDMS while ensuring Right First Time metrics. -Ensured all documents adhered to format standards, all referenced documents were referenced appropriately, numbering was accurate, and no spelling/grammar errors were present.-Managed document due dates by tracking document status in Excel, following up with reviewers and approvers if review was not performed in a timely manner.-Worked with document control to establish correct effective dates and ensure related documents went effective together and on time.-Created Training Outlines for SOPs and WIs when revised, worked with training team and SMEs to come up with training plans.

GxP laboratory handling donor material with a goal to help patients suffering from c. Diff. Used SOPs to perform material processing, recording, verification, labeling, storage in a TCU, and shipment; along with cleaning and disinfecting practices throughout processes.-Maintained compliance of SOPs and data integrity through FDA audits, to FDA approval and the commercialization of the first oral microbiota-based therapeutic.-Utilized root cause analysis methods to route deviations, investigations and effectiveness checks to closure in the Veeva system when a non-conformance of an SOP occurred.-Managed donor samples determining where to store and send material for both testing and manufacturing, along with preparing the appropriate requisition forms and manifests.-Ensured accuracy when performing data entry of samples in multiple systems such as physical TCU inventory logs, Excel sheets, Oracle Inventory Management and Wellsky EDC.-Qualified trainer for all lab processes, trained three new team members using both on the job training and instructor led training.-Worked with a team across three different sites to write an OJT involving testing donor material, then trained all laboratory team members on the process.-Attended weekly training meetings with other qualified trainers across the donor program discussing upcoming projects.-Worked with program director, project managers and two other laboratory associates to evaluate and standardize work across donor sites.-Extended travel to Tempe, AZ to aid their site with material processing during their opening months.-Forecasted samples by corresponding daily with various vendors to schedule pickups and drop off of donor material and supplies.-Maintained and documented monthly inventory counts of all laboratory supplies.

Greater Boston Area

• Employee of the month for January 2017.• Trained many new crew members in all aspects of the workplace.• Worked effectively with my coworkers to ensure customer satisfaction.• Excellent multitasking skills.• Experience with closing shifts.

Wilmington, Massachesetts

• Examined medical documents, extracted needed information and sorted them into appropriate folders.• Completed tasks accurately and timely.• Exceptional computer skills.