Ashley Crowell Email & Phone Number

Mertztown, Pa, Us

• Perform and/or facilitate data collection/entry, investigation, closure, customer communication, and file storage for customer complaints• Support regulatory compliance of complaint system, including Medical Device Reporting, field action and other regulatory reporting as necessary• Performs trending analysis and reports to management during complaint reviews.• Ensures timely completion of complaint investigations and reports per regulatory requirements.• Act as primary contact with distributors and third party manufacturers on the complaint handling process.Facilitate investigation and resolution of CAPA report functions (Nonconformances and Corrective/Preventive Action) with the organization• Ensure nonconformances are thoroughly and timely investigated• Facilitate the approval of nonconformance investigations via the Material Review Board• Data collection and entry of CAPA information into the CAPA system

Allentown, Pennsylvania, United States

• Perform routine and non-routine sterility testing on sterilized loads, including validations and Gamma radiated devices.• Perform environmental monitoring as per standard operating procedures, as well as conduct special tests when requested.• Conduct quality control (sterility/growth promotion) on in house and purchased media • Responsible for product bioburden send outs and analyzing of data• Initiate and perform discrepancy investigations within a timely manner to address sterility, environmental or bioburden failures.• Assist in CAPA meetings to remediate laboratory issues/errors• Perform change controls for new equipment and procedure revisions• Complete microbial identifications• Maintain inventory stock for the microbiology department to ensure testing can be completed• Schedule equipment calibration with outside vendors as well as the metrology lab• Revise lab procedures and develop knowledge assessments and skills assessments• Complete micro trending of biological indicator testing, discrepancies and environmental monitoring points using Excel• Assist in training of new hires to comply with GMP, FDA and ISO regulations

West Point, Pa

• Qualified in cell culture of RK-13 cell line• Qualified in cell culture of Vero cell line• Assist in training of new hires to comply with cGMP and SOP guidelines• Responsible for the schedule of assays and ensuring equipment is available for testing• Maintain inventory of critical reagents within the laboratory to sustain productivity• Receive samples from GMP laboratories and update LIMS inventory• Maintain a professional and quality relationship with clients

West Point, Pa

• Carried out potency testing on MRC-5 cell line• Purification and maintenance of tissue culture using aseptic technique• Performed serial dilutions, pipetting, preparing media and chemicals needed to treat cells• Obtained cell count through the use of a hemacytometer• Analyzed and input results into LIMS• Responsible for chemical disposal of lab materials following OSHA standards• Worked independently and efficiently alone and with team members

Bachelor Of Science (B.S.), Cell/Cellular And Molecular Biology

Activities and Societies: Biology Mentor

Biotechnology