Christopher Carlson Email & Phone Number

Seattle, Washington, United States

Greater Los Angeles Area

• Serves as the lead contact with CMO partners about the transfer and execution of production and stability processes.• Authored or revised at least 100 SOPs, work instructions, protocols, test methods, and reports.• Developed document control system by making documents effective and scheduling training.• Reviews external bulk manufacturing and packaging batch records for completeness and adherence to internal standards, quality agreement, and CFR alignment.• Regularly communicate with external partners about scheduling, production runs, change requests, and ongoing quality control data.• Prepares device history records for each medical device batch.• Led project with production department to improve batch record efficiency and consistency.• Coordinated with the QC department to revise work instructions for environmental monitoring and the water system to increase clarity and incorporate feedback.• Functioned as lead project driver to revamp HPLC and concentration test methods to align with new suite of products.• Investigated dozens of NCRs and drove multiple change controls and out-of-specifications.• Authored multiple annual stability reports for ten different company materials and final products.• Continues to function in multiple roles as previous position.

Claremont, California

• Originally functioned as sole QA department contact at mid-level pharmaceutical company.• Reviewed internal batch records, test reports, stability test data, validation information, and other miscellaneous production and quality control-related documentation.• Upgraded and employed non-conformance, out-of-specification, planned deviation, and product complaint systems at global level.• Conducted ten on-site production audits for suite of medical device and oral cosmetic products.• Developed first training tracker system and created training schedules for departments.• Authored and revised dozens of SOPs, work instructions, protocols, test methods, and reports.

Greater Los Angeles Area

• Performed QC testing on over 100 incoming raw materials according to regulations and material specification requirements, utilizing medley of laboratory instruments and proper record keeping.• Enhanced facility document control by creating and revising over 500 official documents, including SOPs and raw material specifications, to create stronger quality standards, to adapt to changing compendial requirements, and to continue cGMP process improvement.• Collaborated with interdepartmental teams to manage and edit specification requirements in order to meet new regulatory requirements and to improve consistency for all materials through gap analysis and syncing with additional requirements from a division or regulatory standpoint.• Investigated laboratory events for out-of-specification and out-of-trend deviations using the CAPA, Trackwise, and change control systems, while serving as a yellow belt in continuous improvement processes.• Emerged as a leader for material specification conversion project, aiming to align all facilities with the same testing procedure for raw material testing.• Improved lab safety practices and controls by pursuing ongoing project to relay unique reagent hazard warnings to lab analysts through job hazard analysis and procedure revision.• Performed initial validation for newly developed assay protocol to test VHP concentration during packaging of experimental medical product.• Trained as an audit scribe to serve in regulatory audits.

Greater Los Angeles Area

• Carried out critical cell culture and purification activities in aseptic manufacturing area with constantly evolving priorities.• Strictly followed SOP and cGMP standards with proper documentation.• Updated instructions on dozens of SOPs, forms, and other documents for cGDP compliance and efficient document flow.• Spearheaded validation project to dramatically increase efficiency by regulating cleaning labware.• Coordinated successful interdepartmental project to standardize media preparation for lab testing.• Served on multiple kaizen projects and continuous improvement teams to create better process flow in multiple areas.• Served as mentor for new hires and trained coworkers on over 40 SOPs to strengthen expertise and raise awareness for various audits.