Colton Schumacher

• Incorporated Lean Six Sigma methodologies into daily operations, reducing inefficiencies while maintaining high levels of product quality.
• Served as subject matter expert for all matters related to quality assurance within the organization, providing guidance and support when needed.
• Assisted in vendor selection and qualification, ensuring only high-quality suppliers were engaged in company projects.
• Conducted root cause analysis on reported defects, leading to corrective action plans that mitigated future issues.

Lead Quality Engineer (October 2022-Present)

Quality Engineer (June 2022-October 2022)

• Wrote and executed studies to identify process areas that could be improved using lean manufacturing principles.
• Wrote, reviewed, and executed change controls to update/improve current SOPs, BPRs, MMRs, FORMs, and WIs in accordance with regulatory and company guidance.
• Reviewed documents from validation engineering department from quality perspective (IQ/OQ/PQ/PPQ).
• Collaborated with other departments to facilitate successful project completion.
• Review Batch Production Records (BPRs) of in-process and finished goods prior to release.
• Trended various metrics to present to leadership team on quarterly updates.
• Oversaw CAPA program to implement changes with end goal of implementing continuous process improvement and lean manufacturing.
• Worked with third-party laboratories in creating/reviewing testing methods in accordance with regulatory guidelines.
• Participate in third-party audits (Board of Pharmacy, FDA, DEA).
• Trained and mentored junior engineers, providing guidance and direction which included implementing quarterly goals to be met.

• Wrote customer product complaints using risk based approach (FMEA).
• Wrote Risk Assessment Memorandums (RAMs) to ensure proposed changes to production process, materials used, and other changes met regulatory and company guidance and posed no risk to any process.
• Trained new Quality Assurance staff on writing product complaints.
• Assisted Quality Control staff in daily tasks as needed (paperwork review, in-process production checks, third-party testing communication).
• Trained to cGMP & cGDP and provided guidance to entry level Quality & Production personnel as needed.
• Assisted Production staff in SO 8 cleanroom.
• Wrote and reviewed nonconformance investigations/deviations in accordance with company and regulatory guidelines for 503b facility and dietary supplement facility.