Location: Detroit, MI Department: Centralized Pharmacy Service Center (CPSC) Reports To: Pharmacy Manager, Centralized Sterile Compounding Center (CSCC)
Position Overview
Come join the Henry Ford Health (HFH) corporate pharmacy team to create the future of pharmacy practice in Southeast Michigan. We are seeking a highly skilled and detail-oriented Pharmacy Specialist to join our Centralized Sterile Compounding Center (CSCC) team.
This role supports sterile compounding operations across the HFH enterprise to ensure safe, compliant, and high-quality compounding practices. The preferred candidate must have demonstrated experience with sterile compounding workflows and regulations, 503a/b outsourcing facility functions, environmental sampling and monitoring, and microbiology report assessment.
Job duties:
Evaluates laboratory quality reports to approve release of quarantined Compounded Sterile Products (CSPs)
Participates in oversight of sterile compounding activities, and performs final CSP visual inspection, verification, labeling, and storage
Develops and maintains all required documentation for cleanroom facilities and environment
Assists in evaluation and deployment of new CSPs
Analyzes and summarizes quarterly quality report findings from 503a/b business partners
Develops and maintains all required documentation for patient-specific and anticipatory batch sterile compounded products
Participates as a member on or leader of departmental and health-system committees
Collaborates with pharmacy staff to maintain an accurate medication and supply inventory
Ensures compliance with USP, state, federal and regulatory sterile compounding standards, and HFH policies and procedures pertaining to sterile compounding
Develops and updates standard operating procedures, training materials, and compounding records
Oversees and reviews personnel media fill testing, gloved fingertip sampling, etc.
Provides quality assurance and best practice education
Investigates deviations, errors, or complaints related to sterile compounding and develops Corrective and Preventive Action (CAPA) plans
Partners with departments and committees to identify and implement process improvements – enhancing service, quality, and operational excellence
Prepares the pharmacy for inspections including but not limited to, FDA, NABP, DEA, TJC, state boards of pharmacy
Acts as operational leader in the managers absence
Job Requirements:
Minimum of 3-5 years of experience in sterile compounding, designated person for one or more sites, and/or quality assurance in an acute care, health system, or 503a/b setting
Comprehensive knowledge of USP <797>, USP <800>, FDA regulations, and other applicable sterile compounding standards
Previous experience with quality assurance programs, audits, and regulatory compliance in sterile compounding preferred or as designated person
Must be licensed or eligible for licensure in the State of Michigan. If eligible, licensure must be obtained within 30 days of hire; failure to obtain licensure will result in termination of employment
Board certification or ASHP certification in sterile compounding is preferred at time of hire or must be completed post-employment
Henry Ford Hospital is an 877-bed academic facility and Level 1 trauma center in Detroit, Michigan. It is the largest hospital among the 13 acute-care hospitals that comprise Henry Ford Health. The hospital is recognized for clinical excellence in the fields of cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, transplant, and cancer.