Kevin Lin Email & Phone Number

Oceanside, California, United States

Oceanside, California, United States

Oceanside, Ca

• Perform and write investigations and product impact assessments for AHF-M and Albumin department on Trackwise 8• Perform quality review on Albumin and AHF-M batch records for submission to quality release and to address any customer product complaints• Improve and revise manufacturing documents and SOPs in order to reflect current practices, reduce documentation errors, and prevent future nonconformance from occurring• Work with Fractionation and Filling Department to resolve any… Show more • Perform and write investigations and product impact assessments for AHF-M and Albumin department on Trackwise 8• Perform quality review on Albumin and AHF-M batch records for submission to quality release and to address any customer product complaints• Improve and revise manufacturing documents and SOPs in order to reflect current practices, reduce documentation errors, and prevent future nonconformance from occurring• Work with Fractionation and Filling Department to resolve any issue and to ensure production schedule is on time• Attend exception management meetings that occur twice a week to discuss current production observations that may need a Trackwise 8 exception • Review functional design specifications for future EBM Work Orders with current Albumin production run sheets and discuss any issues with IT• Prepare Flexbumin and Nano-AHF-M for shipment to Round Lake and Thousand Oaks respectively• Train newly employed Quality Analyst on position responsibilities in both Albumin and AHF-M manufacturing processes that include stationary tank readings, portable tank use, cuno-clarification process, ultrafiltration/diafiltration process, sterile filtration, pasteurization, Mab/Q column process, and Nano-filtration cleaning and process Show less

Los Angeles

• Performed real time review on Albumin and AHF-M Batch Records for accuracy, compliance, and GDP• Attended daily meetings with manufacturing personnel about schedule changes, procedural deviations, and day to day activities• Reviewed equipment documents that included CIP/SIP logs, autoclave runs, weekly/daily cleanings, cleaning solution make-up, pH log, and ultrafiltration system cleanings• Provided guidance to Albumin and AHF-M manufacturing operators with regards to critical… Show more • Performed real time review on Albumin and AHF-M Batch Records for accuracy, compliance, and GDP• Attended daily meetings with manufacturing personnel about schedule changes, procedural deviations, and day to day activities• Reviewed equipment documents that included CIP/SIP logs, autoclave runs, weekly/daily cleanings, cleaning solution make-up, pH log, and ultrafiltration system cleanings• Provided guidance to Albumin and AHF-M manufacturing operators with regards to critical steps and quality procedures like pulling lab samples or sterile set-up• Observed manufacturing operators in an ISO-8 environment to ensure cGMP and compliance are being followed• Issued manufacturing run sheets and LIMS sample labels to the Albumin and AHF-M department Show less

Greater Los Angeles Area

• Managed packaging inventory with JD Edwards• Performed AQL during packaging of Buminate and AHF-M• Attended daily meetings with planning, packaging, release, filling, and warehouse departments to ensure production supplies are available per the production schedule and to resolve any issues• Calibrated the NERI Labeler and packaging equipment to ensure accuracy prior to use• Trained quality inspectors on cGMPs, GDPs, SOPs, and job responsibilities• Observed the fill/finish… Show more • Managed packaging inventory with JD Edwards• Performed AQL during packaging of Buminate and AHF-M• Attended daily meetings with planning, packaging, release, filling, and warehouse departments to ensure production supplies are available per the production schedule and to resolve any issues• Calibrated the NERI Labeler and packaging equipment to ensure accuracy prior to use• Trained quality inspectors on cGMPs, GDPs, SOPs, and job responsibilities• Observed the fill/finish area and perform quality checks on operators’ performance Show less