Facility Sterile Compounding Inspector

State of Maryland•Baltimore City, MD

3d•Hybrid

About The Position

A Laboratory Scientist Surveyor I is the full performance level of work assessing and evaluating the quality of sterile compounding establishments permitted by the Board and the product it produces to ensure that patients receive drug products compounded in accordance with State and federal laws, regulations and USP 797 guidelines. This position will conduct on site compounding facility inspections to ensure compliance with state and federal law; and interpret environmental viable airborne particle testing and non-viable environmental testing, deviations from fingertip touch testing and media fill testing and other tests related to patient/product safety. This position will inspect hospital and pharmacy compounding equipment and procedures and determine if the operating standards are in alignment with state and federal laws. This position will review documentation including test reports related to pyrogen and pathogen toxicity, efficacy, and potency. This position will also evaluate facility quality control standards and if required, ensure changes are made to quality control procedures to bring the policies in place to an acceptable standard by assisting in the development of a corrective plan of action. This position will review application documentation that assures that any ingredient used in compounding the drug complies with the standards of the applicable United States Pharmacopeia or National Formulary monograph, or of another compendium or pharmacopeia recognized by the Secretary for the Food and Drug Administration and that the drug is not identified (directly or as a part of a category of drugs) on a FDA list of drug shortages. The Laboratory Scientist Surveyor I will perform the full range of duties under general supervision. In addition, this position will provide policy advice to clinical staff on laboratory workers and technicians on licensing qualifications; and will also recommend sanctions and disciplinary action if needed. This position is hybrid telework eligible.

Requirements

A Bachelor’s degree in Biochemistry, Biology, Biotechnology, Chemistry, Genetics, Immunology, Microbiology, Molecular Biology, or Medical Technology from an accredited college or university.
Two years of experience working in a medical or public health laboratory performing diagnostic or public health testing on human specimens.
Candidates may substitute U.S. Armed Forces military service experience as a commissioned officer in Health Science Research Officer classifications or Medical Laboratory Specialists specialty codes in the Science related field of work on a year-for-year basis for the required experience and education.
Possess a motor vehicle operator’s license valid in the State of Maryland.

Nice To Haves

Attention to detail.
Excellent oral and written communication skills.
Experience effectively multitasking.
Experience working with a team.

Responsibilities

Conduct on site compounding facility inspections to ensure compliance with state and federal law.
Interpret environmental viable airborne particle testing and non-viable environmental testing, deviations from fingertip touch testing and media fill testing and other tests related to patient/product safety.
Inspect hospital and pharmacy compounding equipment and procedures and determine if the operating standards are in alignment with state and federal laws.
Review documentation including test reports related to pyrogen and pathogen toxicity, efficacy, and potency.
Evaluate facility quality control standards and if required, ensure changes are made to quality control procedures to bring the policies in place to an acceptable standard by assisting in the development of a corrective plan of action.
Review application documentation that assures that any ingredient used in compounding the drug complies with the standards of the applicable United States Pharmacopeia or National Formulary monograph, or of another compendium or pharmacopeia recognized by the Secretary for the Food and Drug Administration and that the drug is not identified (directly or as a part of a category of drugs) on a FDA list of drug shortages.
Provide policy advice to clinical staff on laboratory workers and technicians on licensing qualifications.
Recommend sanctions and disciplinary action if needed.