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
• 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

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
• 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

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