Stephen Craig Email & Phone Number

Greater San Diego Area

San Diego, Ca

Managed the GMP training program and Learning Management System.Initiated quarterly training compliance reviews, resulting in no audit observations issued from FDA.Worked with HR, Legal, Regulatory Affairs and other departments to assess training needs and standardize training curricula, improving compliance and reducing time and effort to onboard new hires.As LMS system administrator, performed implementation, maintenance, validation activities. Due to improved process efficiency, less than half the business and IT resources were needed, compared to the previous system.Managed offsite archival of all paper training records. Developed efficient tracking system efficient that required only one summer intern to complete inventory.

San Diego, Ca

Established formal training program and replaced Learning Management System.Implemented new Saba Learning Management System (LMS), improving curriculum management and training compliance across the company, and over 50% annual cost savings.Consolidated and entered training forms into LMS, enabling managers to directly monitor employee training status. Reduced training form processing time by training new LMS administrators across two company sites.Optimized custom training reports by collaborating with vendor, analyzing defects, and revalidating the new reports. Report server crashes were eliminated, and large reports ran up to 90% faster.

San Diego, Ca

Internal, external, study phase auditsPerformed gap analysis, revised existing processes, and wrote new SOPs, eliminating redundant paperwork and cutting processing time by 50%. Efficiently managed closeout of GLP QA program, requiring only one part-time contractor, despite the loss of many key personnel due to company downsizing.

San Diego, Ca

Administered new hire, software, technical training and overall training programOverhauled existing GMP new hire orientation process, updated training materials, and shortened process from several weeks to two days.Implemented laboratory analyst qualification training program. Lab personnel qualification time reduced to two weeks, and turnover rate dropped 33%.Rapidly integrated site into the new Cardinal Health division by implementing mandated Documentum EDMS and ComplianceWire LMS in half the time required by other sites. Advised other sites on implementation and trained over 200 employees at a sister facility.

San Diego, Ca

Developed, validated, and transferred analytical methods to contract laboratories. Wrote SOPs for analytical methods, instrument maintenance, and notebook documentation. Supervised and trained the laboratory assistant.

Carlsbad, Ca

Performed GMP in-process, stability, release, and raw materials testing of oligonucleotides. Trained new lab personnel to perform UV, HPLC, and gel electrophoresis testing.