Meghan Ludlow Email & Phone Number

Buffalo, New York, United States

Buffalo, New York, United States

♦ Collaborated with R&D and Manufacturing teams during product development and to make various improvements to ongoing manufacturing processes.♦ Assessed the risk and potential design impact associated with non-conformance reports, deviation reports and procedural change control reports to ensure compliance with the standards set forth by ISO 13485 and FDA 21 CFR part 820.♦ Ensured continuous improvement to company’s quality management system by identifying any problematic trends and innovating creative solutions.♦ Served as SubAdmin for company’s electronic QMS MasterControl: Implemented new document configurations, assigned/modified users account rights and roles, assigned training as needed, etc.♦ Performed investigations into problematic trends, customer complaints, product failures, and root cause for corrective and preventative actions.♦ Provided guidance and training to numerous employees on quality standards, processes and regulatory requirements.♦ Provided troubleshooting to existing MasterControl processes and configuration.♦ Collaborated with R&D and Manufacturing teams to create and revise stability and validation protocols and reports.♦ Participated in an FDA Audit (War Room).♦ Reviewed and revised countless standard operating procedures and test method procedures.

Buffalo, New York, United States

♦ Assessed the risk associated with non-conformance reports and process deviations to ensure compliance with the standards set forth by ISO 13485 and FDA 21 CFR 820.♦ Collaborated with colleagues to implement new electronic process for all departmental training logs.♦ Disposition of and reviewal of batch production records for procedural adherence, good documentation practices and assurance that all material specification requirements are met.♦ Ensured continuous improvement to company’s process deviation and non-conforming material systems by identifying any problematic trends and suggesting solutions that align with the quality management system.♦ Managed documentation using electronic QMS Master Control.♦ Monitored the deionized water system for microbial presence.♦ Performed validation and calibration of laboratory equipment including pH meters, plate readers, shakers, spectrophotometers and various incubators.

Fredonia, New York, United States

♦ Provided exceptional customer service to each table.♦ Balanced needs of countless customers at a time.♦ Trained new servers how to use the point-of-sale system.

Dunkirk, New York, United States

♦ Assisted multiple company sites with data compilation and trending to submit for FDA approval.♦ Authored several technical procedures per current regulatory guidelines set by the United States Pharmacopeia, ISO 9001 and FDA 21 CFR 210 & 211.♦ Developed departmental budgets for various microbiological test procedures.♦ Ensured continuous improvement to company’s process deviation and non-conformance systems by identifying problems and suggesting solutions that align with the quality policy.♦ Established test method procedure to perform microbial and fungal identification in house.♦ Implemented aseptic training program for all applicable personnel.♦ Managed documentation using electronic QMS Veeva.♦ Performed kinetic chromogenic endotoxin determination of facility water for injection system.♦ Performed serial dilutions of reference standards using a repeater pipette.NOTE: ImmunityBio acquired Athenex Dunkirk Site in February 2022.

Dunkirk, New York, United States

Reference ImmunityBio position above.

Dunkirk, New York, United States

♦ Authored standard operating procedures for operation of all laboratory equipment for the facility.♦ Developed 503B media fill validation protocol for the facility.♦ Ensured continuous improvement to company’s quality management system.♦ Evaluated the highest risk points in clean rooms to assist with development of the environmental monitoring program for the facility.♦ Executed microbiological test procedures for bioburdens, coliforms, product sterility, water for injection system, and identification of microbial isolates.♦ Investigated results of performance qualification of sterile cleanrooms.♦ Managed documentation using electronic QMS Master Control.♦ Performed environmental monitoring of sterile cleanrooms.

Hamburg, New York, United States

♦ Supervised daily front-of-house operations.♦ Led a team of servers that provided exceptional customer service to each patron visiting the establishment.♦ Designed sections and side work checklists for servers.♦ Supported upper management with the organization and implication of a new point-of-sale system.♦ Trained new team members on all applicable job responsibilities.♦ Managed front-of-house inventory and assisted with staff scheduling as needed.♦ Established new operating procedures during a global pandemic.♦ Operated a multi-line phone system in large volumes during government-mandated shutdowns.

Blasdell, Ny

♦ Provided exceptional customer service to each patron.♦ Maximized store sales.♦ Delegated tasks to each team member.♦ Trained new team members on all applicable job responsibilities.♦ Balanced the cash drawer at the beginning and end of each shift.

Bachelor Of Science - Bs, Biomedical Sciences, General

Activities and Societies: Dean’s List

Advanced Regents Diploma, Honors In Math & Science, High Honors

Activities and Societies: Foreign Language Hall of Fame, Spanish Club & Art Club