You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

The Pharmacist-in-Charge (PIC) is responsible for the overall supervision, management, and regulatory compliance of all pharmacy operations within the 503B Outsourcing Facility. This position ensures full compliance with FDA Current Good Manufacturing Practices (CGMP), USP <797>, <800>, and <795> standards, and all state and federal pharmacy regulations. The PIC serves as the primary liaison for inspections and audits, ensures product quality, and upholds the highest standards of patient safety, documentation integrity, and operational excellence.

Key Responsibilities

• Ensure compliance with FDA 503B Outsourcing Facility requirements, DSCSA Track & Trace, DEA, and State Board of Pharmacy regulations.
• Maintain and oversee all state and federal licenses, permits, and registrations.
• Serve as the point of contact for FDA, DEA, and State Board inspections, audits, and regulatory correspondence.
• Review, approve, and maintain SOPs, Master Batch Records (MBRs), validation protocols (IQ/OQ/PQ), and associated documentation.
• Oversee compliance with environmental monitoring, media fill, personnel qualification, and gowning validation programs in accordance with CGMP and USP requirements.
• Supervise all aseptic compounding, labeling, packaging, and product release operations.
• Verify sterility, potency, stability, and analytical data prior to product release.
• Oversee batch record review, deviation and OOS investigations, and CAPA implementation.
• Ensure inventory control for APIs, excipients, and finished goods with full lot traceability and expiration monitoring.
• Coordinate with QA/QC to ensure timely product disposition and documentation accuracy.
• Supervise and evaluate performance of pharmacists, technicians, and support staff.
• Enforce aseptic technique, behavioral standards, and cleanroom gowning protocols in ISO-classified areas.
• Conduct staff training, competency assessments, and performance reviews.
• Support a quality-first culture emphasizing regulatory compliance, accountability, and continuous improvement.
• Maintain all required manufacturing, quality, and compliance records, including equipment logs, calibration, cleaning, vendor COAs, and distribution documentation.
• Ensure compliance with DSCSA Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for all distributed drug products.
• Approve non-patient-specific orders and compounding batch records in accordance with CGMP and FDA guidance.
• Assist with internal audits, product complaints, recalls, deviations, and adverse event reporting.
• Review and approve sterility testing, environmental monitoring reports, and stability program data.
• Participate in change control reviews, risk assessments, and validation lifecycle management.

Qualifications

• Doctor of Pharmacy (Pharm.D.) or Bachelor of Science in Pharmacy (BSPharm).
• Active and unrestricted Florida Pharmacist License (multi-state licensure preferred).
• Minimum 1 year of experience in a 503B Outsourcing Facility is required.
• Preferred: 3–5 years total experience in sterile compounding, with at least 1 year in a 503B facility.
• Candidates with 1 year 503B experience and 2–5 years 503A sterile compounding experience will also be considered.
• Strong working knowledge of CGMP, 21 CFR Parts 210/211, USP <797>/<800>, and DSCSA compliance requirements.
• Experience with regulatory inspections, validation protocols, and environmental monitoring programs highly preferred.
• Excellent communication, organizational, and leadership skills required.

Additional Requirements

• Must be able to work within ISO 7/ISO 8 classified cleanroom environments following aseptic gowning procedures.
• Ability to stand for extended periods during sterile operations.
• Must adhere strictly to gowning, aseptic, and contamination control standards.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

Required Employment / Compliance Language

Medix is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.