Melanie Gilbert

Medicinal Cannabis Sciences and Therapeutics: Basic science (pharmacology, chemistry, and medical cannabis delivery systems), Clinical uses (pathophysiology, assessment, and management of conditions that may be treated by medical cannabis), Adverse effects and public health considerations, Federal and state laws and policies.
Courses:
Medical Cannabis History, Culture, and Policy; Drug Action and Cannabinoid Pharmacology; Cannabinoid Chemistry and Drug Delivery; Clinical Effects of Medical Cannabis; Advanced Cannabis Therapeutics I & II; Genomics and Pharmacognosy; Advanced Cannabinoid Chemistry and Analytic Testing Methodology; State and Federal Cannabis Laws and Policies; Research Design and Medical Cannabis

Farmer Bros. Co. - Corporate 2016 to Present
Paralegal, Property Manager (09/2019 to Present)
Regulatory Compliance Analyst (07/2016 to 09/2019)
Vertical promotion to a role with increasing scopes of responsibility especially surrounding the legalities of document control and regulatory compliance. Earned through diligence, natural leadership skills, and the unmatched ability to master complex concepts quickly in alignment with policies, procedures, and regulations.
 Manage, oversee, and ensure compliance with contractual lease and real estate terms and regulations coast to coast.
 Research issues and develop guidance and recommendations for resolving various regulatory deficiencies, complaints and recommend solutions. Interpret regulatory rules, keeping abreast of changes, to develop and implement program policy and procedures to successfully meet goals and requirements of the organization, and related statutes and regulations compliant with various state and local agencies.
 Technical review of data reports to assure scientific accuracy and clarity of presentation, including product promotional materials, labeling, batch records, specification sheets and testing methods for compliance with regulations and company policy. Provide employee training on regulatory labeling and import/export requirements.
 Maintain current knowledge base of existing and emerging regulations, standards and guidance to communicate changes internally. Research industry trends and assess technological advantages to the types of regulatory submissions or internal documentation required in collaboration with various departments, ie legal dept.
 Employ unparalleled commitment and understanding of business direction, goals, objectives, and missions to align implemented enhancements and author new Standard Operating Procedures (SOPs) to meet business needs.

Cellmark Forensics (LabCorp Specialty Testing) 1998 to 2016
Quality & Regulatory Compliance, Document Control Manager
Worked through several roles including Administrative Assistant, Serologist, Laboratory Technician, Data Analyst and EHS Officer to earn the coveted title of Regulatory Compliance Manager. Directed and supervised 15 people in Chain of Custody procedures including disposition of evidence in alignment with contractual guidelines.
 Receive and review incoming documents and evidentiary items maintaining Chain of Custody at every process conforming to appropriate local, state, and/or federal rules, procedures and requirements. 15 years (2001-2016)
 Interact with public and clients to provide information on legal and DNA testing requirements, shipment and disposition of evidence requirements. Conducted laboratory screening, extraction, quantification and post lab analysis of submitted samples. Assign unique case number and assign to analyst for further testing and/or review. Sort, classify, copy, scan, file and maintain confidentiality and integrity of records. Certify documents are true and correct copy of original file. Answer inquiries on case status and procedural questions. 15 years (2001-2016)
 Ensured staff technical acumen and regulatory compliance by training on the accreditation, compliance, and laboratory safety standards of ASCLD/LAB-International, FBI QAS, DAB, AABB, multiple state DOH agencies, OSHA, ANSI and NIST. 10 years (2006-2016)
 Monitor creation, storage, retention, retrieval, destruction, recovery compliance, and QMS Document Control under ISO/IEC 17025:2001 standards. Research issues and develop guidance and recommendations for resolving various disposition and related records management issues. 10 years (2006-2016)
 Identified and corrected procedural and quality gaps to fuel compliance and implemented corrective actions garnered from internal and external audits. 10 years (2006-2016)
 Develop and implement program policy and procedures to successfully meet goals and requirements of the organization, and related statutes and regulations. 10 years (2006-2016)