Title: Senior Investigator Drug Control Program
Organization: The Massachusetts Department of Public Health
Brief Summary of Position:
The Massachusetts Department of Public Health’s (DPH) Bureau of Health Professions Licensure is comprised of the ten Boards of Registration and Certification and the Drug Control Program and Prescription Monitoring Program. The Food & Drug Inspector II will Inspect, survey and investigate controlled substance registrants including but not limited to health care facilities (hospitals, clinics, long-term care, prisons, etc.), manufacturers, researches and community programs to determine compliance with statutory provisions and regulations of the Department. Provide technical assistance, guidance and consultation to registrants and undertake regulatory actions in order to improve compliance Conduct routine inspections, re-inspections and investigations to determine conformance and compliance with laws, rules, regulations, policies, procedures, standards and guidelines governing controlled substance; enforce state laws and regulations governing controlled substances at health care facilities, manufacturers, distributor, community programs and other Massachusetts Controlled Substance Registration (MCSR) registrants which may necessitate and include conducting an investigation into the misappropriation of controlled substances.
Duties and Responsibilities:
- Inspect, survey and investigate establishments engaged in the manufacturing, handling, storage, distribution, study, administration and/or sale of drugs, and evaluate the security of such drugs on premises to determine compliance with applicable statutory provisions, regulations, and DPH policies.
- Inspect drugs and review drug records for compliance with governing statutory and regulatory standards and takes appropriate action.
- Oversee and coordinate activities relative to the inspection of drugs to ensure compliance with established standards.
- Obtain evidence and establish facts concerning suspected or alleged violations of laws, rules and regulations governing drugs through interviews and observations.
- Conducts investigations related to drug diversion and consumer complaints.
- Prepare reports concerning inspections and related activities to provide information and make appropriate recommendations.
- Testify at hearings relative to the violation of laws, rules and regulations pertaining to drugs.
- Review applications for new or renewed registrations to determine completeness and accuracy of information and compliance with legal requirements.
- Provide liaison between the DCP and other federal and state regulatory agencies to exchange information and better coordinate enforcement of laws, rules and regulations as they relate to public health.
- Exercise embargo powers upon examination and evaluation of drug products suspected to be adulterated or misbranded or otherwise unfit for human consumption and assist in supervising and overseeing their confiscation and/or destruction when laboratory analysis substantiates adulteration.
- Obtain samples of drug products for laboratory analysis to determine variances between analyses and drug product specifications.
- Initiate regulatory and court enforcement procedures in instances of non-compliance.
- Conduct routine and special sampling programs to assure compliance with standards of quality, identity and purity.
- Provide consultation and training to local boards of health and their agents regarding inspectional and investigative techniques.
- Evaluate labeling, answer correspondence, perform statistical evaluation of inspectional and laboratory reports, collect information on specific topics and perform related work as required or directed.
- Maintain investigation and inspection files and records.
- Respond to inquiries from registrants, stakeholders and members of the public.
- Knowledge of the principles and practices of drug security and accountability.
- Knowledge of the terminology and standard abbreviations used in health care facilities and health care facility records, including dug security and accountability documentation.
- Knowledge of the types and uses of equipment and electronic systems used to track drugs in health care facilities.
- Knowledge of the common factors, trends and problems in health care facilities related to drug security and accountability.
- Knowledge of the methods of technical report writing.
- Ability to understand, explain and apply the laws, rules, regulations, policies, procedures, specifications, standards and guidelines governing assigned unit activities.
- Ability to maintain accurate records.
- Ability to analyze evidence and determine the applicability of health care data, to draw conclusions and make appropriate recommendations.
- Ability to establish a professional relationship with registrants, deal tactfully with registrants and maintain a harmonious working relationship with persons from varies ethnic, cultural and/or economic backgrounds.
- Willingness to diffuse difficult situations and potential confrontation.
- Ability to coordinate the efforts of others to accomplish assigned work objectives
- Ability to communicate effectively in oral and written expression.
- Ability to give oral instructions in a precise, understandable manner.
- Ability to operate a motor vehicle.
- Ability to understand drug analysis laboratory reports; to prepare reports and keep records of inspections.
- Experience in the manufacturing, processing or distribution of drug products, the major duties of which involved the inspection of drug products, or in regulatory or law enforcement work involving the inspection of drug products.
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