Loren Bettermann

• Manage compliance activities for hospital and outpatient operations, supporting adherence to federal, state, accreditation, and organizational requirements.
• Develop and implement compliance auditing tools and monitoring processes for areas including infection control, safety, and operational compliance.
• Lead ongoing policy review and revision efforts to align organizational policies and procedures with evolving regulatory standards and best practices.
• Serve as co-chair of the Emergency Preparedness Committee and contribute to multidisciplinary oversight through participation on Safety, Human Rights, and Accident/Incident committees.
• Participate as a non-voting compliance representative on Pharmacy, Infection Control, and Environment of Care committees.
• Coordinate and update annual emergency preparedness training programs for organizational staff.
• Serve as lead administrator for the organization’s policy management software, including vendor evaluation, implementation support, and ongoing system administration.
• Compile, analyze, and present audit and compliance data through dashboards and reporting tools for senior leadership review.
• Conduct regulatory audits, investigations, and compliance reviews while supporting corrective action and continuous improvement initiatives.
• Act as a resource to departments regarding regulatory interpretation, compliance requirements, and policy guidance.

• Participate in internal, external, and regulatory inspections and audits.
• Managed the raw material program: review and release of raw materials and plasma, components, and labels for GMP use.
• Participate in maintaining and monitoring SAB’s quality management system as required to maintain compliance to GMP regulations.
• Review and approve test methods, manufacturing/quality control qualification, validations protocols and reports.
• Assessment, perform and review non-conformance incidents, deviations, and change control requests.
• Perform, review and approve quality investigations and CAPAs.
• Review equipment, facility and utility IQ, OQ, PQ documents. Assist and deliver quality related training to SAB employees pertaining to GMP regulations.
• Support activities as related to qualification/validation of equipment and processes.

• Daily management of the laboratory including inventory/ordering, cleaning and maintenance of laboratory equipment.
• Review and approve manufacturing production records for compliance to regulations and internal requirements.
• Creating, reviewing and approving documentation such as SOPs, testing methods, and CAPAs.
• Collecting production samples for evaluation and performing analytical lab testing.
• Prepared for Kosher, USDA and FDA audits.
• Document creation and review. Review of processes and internal auditing.
• Responsible for implementing, following and promoting Good Manufacturing Practices (GMP) and FDA requirements.

Progressed through roles in GMP-regulated manufacturing and laboratory environments, supporting quality control, compliance, and process development across food and biotech industries.

• SunOpta Aseptic (QC Lab Technician II): Performed GMP testing, maintained OSHA/safety compliance, supported lean manufacturing initiatives
• Actives Factory (Lab Coordinator Intern): Supported nanoparticle dispersion development, testing, documentation, and root cause analysis workflows
• Enzymology Research Center Catalysts (QC Lab Manager): Managed lab operations, SOP/CAPA systems, and USDA/FDA/Kosher audit readiness